Regulatory Information
OTC Panel Submissions (Indices Only): 14 - Antiperspirant
File July 7, 1975
Panel Administrator
OTC Division
Zirconium Report 75N-0003
| VOLUME | SUBJECT |
|---|---|
| 140032 | Carter-Wallace |
| 140034 | Carter-Wallace |
| 140035 | Gillette - Right Guard Extra Strength |
| 140036 | |
| 140037 | Proctor & Gamble - Secret, Sure |
| 140038 | Proctor & Gamble |
| 140039 | Proctor & Gamble |
| 140042 | Proctor & Gamble |
| 140043 | Proctor & Gamble |
| 140046 | Proctor & Gamble |
| 140048 | Proctor & Gamble |
| 140049 | Carter-Wallace - Arrid XX |
| 140050 | Gillette |
| 140000 |
A - Correspondence File B - Summary Minutes - Antiperspirant Panel C- References |
Docket Number 75N-0003 has been assigned by the Hearing Clerk for the Zirconium Report.
Lee Geismar
ANTIPERSPIRANT OTC DRUGS
DATA AND INFORMATION
| VOLUME | SUBMITTED BY | TRADE NAME | INGEDIENTS AND CONCENTRATION |
|---|---|---|---|
| 140001-3 | Gillette | Right Guard Antiperspirant | 3.4% Al Chlorhydroxide |
| 140004 | Gillette | Right Guard natural Scent Antiperspirant | 3.4% Al Chlorhydroxide |
| 140005 | Gillette | Right Guard Powder Dry Antiperspirant | 3.4% Al Chlorhydroxide |
| 140006 | Gillette | Soft & Dri Lightly Powdered Antiperspirant Deodorant | 3.4% Al Chlorhydroxide |
| 140007 | Gillette | Soft & Dri Unscented Antiperspirant | 3.4 Al Chlorhydroxide |
| 140008 | Gillette | Soft & Dri Scented Antiperspirant | 3.4 Al Chlorhydroxide |
| 140009 | Gillette | X-Hydra Antiperspirant Deodorant Liquid |
20% Active Al Chlorhydroxide 3.6% Al Chloride 5% Cetyl Alcohol |
| 140010 | Gillette | X-Hydra Antiperspirant Deodorant Liquid |
15% Active Al Chlorhydroxide 7.2% Aluminum Chloride 44% Alcohol |
| 140011 | Armour-Dial | Dial Antiperspirant Aerosol | 3.5% Al Chlorhydroxide |
| 140012 | Red Foot | Redfoot |
8-Hydroxyquinoline sulfate 0.75%, Aluminum Potassium Sulfate 1.5%, Salicylic Acid 20%, Boric Acid 10%, Magnesium Stearate |
| 140013 |
Aerosol Techniques Aerosol Techniques Aerosol Techniques |
Antiperspirant Spray Extra Dry Super Dri-Mist Heavy Duty Antiperspirant Rite-Aid Extra Dry Antiperspirant Spray |
3.5% or 4.0% Al Chlorhydroxide Aluminum Chlorhydroxide 5.5% Al Chlorhydroxide complex Al Chlorhydroxide 4.20% |
| 140014 |
Reheis Reheis Reheis Reheis Reheis Reheis Reheis Reheis |
Chlorhydrol Powder Chlorhydrol Solution Micro-Dry Ultrafine Micro-Dry Ultrafine Basic Aluminum Bromide Rehydrol Chloracel Solid Chloracel Solution |
Al Chlorhydroxide Complex Al Chlorhydroxide complex 50% Al Chlorhydrate impalpable Al Chlorhydrate impalpable Basic Aluminum Bromide Al Chlorhydroxide-Propylene Glycol Complex Sodium Aluminum Chlorhydroxy Lactate Sodium Aluminum Chlorhydroxy Lactate 40% |
| 140015 |
Armour-Dial Armour-Dial |
Dial Antiperspirant Roll-On (Scented) Dial Antiperspirant Roll-On (Unscented) |
Al Chlorhydroxide 20% Al Chlorhydroxide 20% |
| 140016 |
Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug |
Body All Powdery Spray Deodorant and Antiperspirant Dorothy Gray Antiperspirant Atomist Deodorant Dorothy Gray Spin Roll-On Deodoorant Antiperspirant Givenchy Gentleman Antiperspirant Deodorant Spray Tussy Dry Antiperspirant Spray Tussy Roll-On Deodorant Tussy Roll-On Deodorant Extra Strength Tussy Roll-On Deodorant (Unscented) |
Al Chlorhydrate 3% Al Chlorhydroxide 2% Alcohol 61% Al chlorhydroxide complex 20% Alcohol 25.17% Al Chlorhydrate 3% Al Chlorhydrate Compound 3.36% Al Chlorhydrate 19.85% Al Chlorhydroxide 24% Al Chlorhydroxide 19.85% |
| 140017 |
Sterling Drug Sterling Drug Sterling Drug Sterling Drug |
Dorothy Gray Antiperspirant Cream Tussy Cream Deodorant Tussy Extra Strength Cream Deodorant Tussy Unscented Cream Deodorant |
Aluminum Sulfate 8.74% Aluminum Sulfate 8.74% Aluminum Sulfate 10.27% Aluminum Sulfate 8.74% |
| 140018 |
Carter Products Carter Products |
Arrid Cream Arrid Cream with Chlorophyll |
Aluminum chlorhydrate 21.25% Aluminum chlorhydrate 21.25% Aluminum Chloride 1% |
| 140019 | Carter Products |
Arrid Antiperspirant Roll-On Deodorant |
Aluminum Sulfate 8% Sodium Aluminum Lactate 8% Water Soluble Lanolin |
| 140020 |
Carter Products Carter Products |
Light Powder Arrid Extra Dry Antiperspirant Spray Light Powder Arrid Extra Dry Unscented Antiperspirant Spray |
Aluminum chlordrate 3.5% Aluminum Chlorhydrate 3.5% |
| 140021 |
Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal Texas Pharmacal |
Allercreme Aerosol Antiperspirant Deodorant Allercreme Aerosol Antiperspirant Deodorant (Unscented) Allercreme Antiperspirant Deodorant Creme Allercreme Antiperspirant Deodorant Creme (Unscented) Allercreme Liquid Spray Antiperspirant Deodorant Allercreme Liquid Spray Antiperspirant Deodorant (Unscented) Allercreme Roll-On Antiperspirant Deodorant Allercreme Roll-On Antiperspirant Deodorant (Unscented) Maxi-Dry Hypo-Allergenic Antiperspirant Roll-On Maxi-Dry Hypo-Allergenic Antiperspirant Roll-On (Unscented) Maxi-Dry Hypo-Allergenic Antiperspirant Cream Maxi-Dry Hypo-Allergenic Antiperspirant Cream (Unscented) |
Aluminum chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Alcohol 58% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 25% Aluminum Chlorhydroxide 25% Aluminum Chlorhydroxide 25% Aluminum Chlorhydroxide 25% |
| 140022 | Carter Products | Zinc Phenolsulfonate | |
| 140023 |
USV Pharmaceutical USV Pharmaceutical USV Pharmaceutical USV Pharmaceutical USV Pharmaceutical USV Pharmaceutical USV Pharmaceutical USV Pharmaceutical |
Mitchum Antiperspirant Spray Mitchum Antiperspirant Spray (Unscented) Mitchum Antiperspirant Spray Powder Mitchum Antiperspirant Spray Powder (Unscented) Mitchum Cream Antiperspirant Mitchum Antiperspirant Scented Liquid Mitchum Antiperspirant Unscented Liquid Mitchum Antiperspirant Stick |
Aluminum Hydroxychloride 2.8% Aluminum Chloride 1.4% Aluminum Hydroxychloride 2.8% Aluminum Chloride 1.4% Aluminum Hydroxychloride 3.5% Aluminum Hydroxychloride 3.5% Aluminum Chlorhydrol 19% Aluminum Chloride 4% Aluminum Chlorhydrol 14% Aluminum Chloride 7.3% Aluminum Chlorhydrol 14.98% Aluminum Chloride 7.79% Aluminum Chlorhydrol 14% Aluminum Chloride 7% |
| 140024-29 |
Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol-Myers Bristol- |
Ammens Foot Powder Ban Roll-On Antiperspirant Deodorant Unscented Ban Roll-On Antiperspirant Deodorant Ban Antiperspirant Cream Deodorant Ban Deodorant Spray Dry Ban Antiperspirnt Deodorant Spray The Dry System Antiperspirant Cream The Dry System Antiperspirant Lotion Concentrate Mum Cream Deodorant Mum Roll-On Deodorant Mum Spray Deodorant Mum Powder Spray Antiperspirant Deodorant Softalc Deodorant Spray Powder Softalc Deodorant Spray Powder (Unscented) Trig Antiperspirant Roll-On Deodorant Trig Antiperspirant Roll-On Deodorant (Unscented) |
Aluminum Chlorhydrate 2% Aluminum Chlorhydrate 22% Aluminum Chlorhydrate Aluminum chlorhydroxide 18.4% Aluminum Chloride 3.6% Aluminum chlorhydrate 1.875% Ethyl Alcohol 53% Aluminum chlorhydrate 3.75% Aluminum chloride 4.5% Aluminum chlorhydroxide 23% Aluminum Chloride 3.6% Aluminum Chlorhydroxide 20.4% Aluminum Chlorhydrate 10% Aluminum Chlorhydrate 10% Aluminum Chlordrate 1.875% Ethyl Alcohol 53% Aluminum chlorhydrate 3.5% Aluminum chlorhydrate 2% Aluminum chlohydrate 2% Aluminum chlorhydroxide 22% Aluminum Chlorhydroxide 22% |
| 140024-29 |
Bristol-Myers Bristol-Myers Bristol-Myers |
Ultra Ban 5000 Antiperspirant Ultra Ban 5000 Antiperspirant (Unscented) Ultra Ban Powder Spray |
Aluminum chlorhydrate 4.04% Aluminum Chloride 0.9% Aluminum chlorhydrate 4.04% Aluminum Chloride 0.9% Aluminum chlorhydrate 3.5% |
| 140030-31 |
Carter Products Carter Products |
Arrid Extra Dry Antiperspirant Spray Arrid Extra Dry unscented Antiperspirant Spray |
Aluminum chlorhydrate 3.5% Aluminum chlorhydrate 3.5% |
| 140032 | Carter Products | Antiperspirant Spray (Experimental) |
Aluminum Chlorohydrate 4% Zirconium chlorohydrate 1% |
| 140033 | Carter Products | Hour After hour Antiperspirant | Aluminum chlorhydrate 3% |
| 140034 | Carter Products |
Aluminum Chlorohydrate Zirconium chlorohydrate |
|
| 140035-36 | Gillette | Right Guard Extra Strength Antiperspirant | Aluminum chlorhydrate, Zirconium oxychloride Aluminum glycinate |
| 140037-38 | Proctor & Gamble | Secret 7 Sure Antiperspirants | Zirconium chlorohydrate, Aluminum chlorhydrate Glycine complex |
| 140039 | Proctor & Gamble | Additional Data | |
| 140040 | FDA Document | 90-day subacute aerosol inhalation toxicity study | |
| 140041 | Pennwalt Corp. | Fresh Stick | Sodium Aluminum chlorhydroxylactate |
| 140042-43 | Proctor & Gamble | Additional Data | |
| 140044-45 | Leon Products, Inc. | Certain-dri | Aluminum Chloride 13.3% |
| 140046 | Proctor & Gamble | Additional Data | |
| 140047 | Leon Products, Inc. | Additional Data | |
| 140048 | Proctor & Gamble | Additional Data | Zirconium-Aluminum-Glycine Complex |
| 140049 |
Carter Products Div., Carter-Wallace, Inc. |
Arrid XX Antiperspirant Spray | Aluminum-Zirconium Chlorohydrate Complex |
| 140051 | Carter Products | Additional Data on Arrid Extra Dry | |
| 140052 | Carter Products | Additional Data on Arrid Roll-on | |
| 140053 | Avon Products, Inc. | Particle size measurements in aerosolized talc | |
| 140053A | Wickhen Products, Inc. |
Wickenol 303 Wickenol 321 Wickenol 323 Wickenol 324 Wickenol 340 Wickenol 363D |
Aluminum Chlorhydrate-50% aqueous solution Aluminum Chlorhydrate crystals Aluminum Chlorhydrate Impalpaple powder Aluminum Chlorhydrate low-moisture impalpaple powder Sodium Aluminum Lactate powder Alcohol Soluble Aluminum Chlohydrate powder |
| 140054 | The Cosmetic, Toiletry, & Fragrance Association, Inc. | Additional information on “Antiperspirant Testing Protocol” | |
| 140055 | Lehn & Fink | Body All--Additional information | |
| 140056 | CTFA | Additional testing procedures | |
| 140057 | Person & Covey, Inc. | Drysol | Aluminum chloride 20% |
| 140058 | Gillette Medical Evaluation Laboratories | Super Dri Soft and Dri and Right Guard Double Protection Roll-on Antiperspirant | 20% Aluminum-zirconyl-hydroxychloride complex |
| 140059 | The Cosmetic, Toiletry and Fragrance Assn., Inc. | Information on ingredient nomenclature | |
| 140060 | Person & Covey, Inc. | Drysol | Additional Data |
| 140061 |
Carter Products Gillette Medical Evaluations Laboratories Sterling Drug, Inc. Revlon Research Center, Inc. Bristol-Myers Proucts The Proctor & Gamble Co. Reheis Chemical Company CTFA Armour-Dial, Inc. |
Nomenclature for ingredients “ ” “ ” “ ” “ ” Nomenclature for ingredients and usage and dosage levels Nomenclature Information on water of hydration for ingredients Nomenclature |
|
| 140062 | The Cosmetic, Toiletry and Fragrance Assn., Inc. | Safety of talc | |
| 140063 | Person and Covey, inc. | Drysol | Additional data |
| 140064 | CTFA | Safety Protocol for aerosols |
| 140065 THRU 140068 |
REFERENCES (Alphabetical by Author) PANEL ADMINISTRATOR’S FILE VOLUME I Members C.V.’s Charge to Panel Summary Minutes Regulatory Analysis Assessment Statement of Exemption and Environmental Assessment Reports PANEL ADMINISTRATOR’S FILE VOLUME II Correspondence |
TFM VOLUME 1400PR has been established for Antiperspirant Drug Products
