OTC - PANEL SUBMISSIONS - INDICES ONLY

 

 

COMMENT FILES FOR PANEL SUBMISSIONS 

 

01        Antacid

            75N-0357

 

02        Antimicrobial I

            75N-0183

 

03        Internal Analgesic

            77N-0094

 

04        Cough-Cold

            76N-0052

            76N-052B Bronchodilators

            76N-052C Anticholinergics & Expectorants

            76N-052G General Comments & Combinations

            76N-052H Antihistamines

            76N-052N Nasel Decongestants

            76N-052T Antiussives

 

05        Sleep-Aids

            75N-0244

 

06        Topical Analgesic

            77N-0334 Topical Otics

            78N-0021 Skin Protectants

            78N-0038 Sunscreen

            78N-0301 External Analgesic

 

07        Antimicrobial II

            80N-0476 Topical Antifungal

            81N-0114 Topical Acne

 

08        Dentifrices and Dental Care Agents

            78N-0196 Oral Mucosal Injury

            80N-0042 Anticaries

            80N-0228 Oral Discomfort

 

09        Laxatives

            78N-0036

            78N-036A Antiemetic

            78N-036D Antidiarrheal

            78N-036E Emetic

            78N-036L Laxative

 

10                Ophthalmic

80N-0145

 

 

11        Contraceptives and Other Vaginal Drug Products

            80N-0280 Contraceptives

            82N-0291 Vaginal

 

12        Memorrhoidal (Anorectal)

            80N-0050

 

13        Oral Cavity

            81N-0033

 

14        Antiperspirant

            75N-0003 Zirconium

            78N-0064 Antiperspirant

 

15        Vitamin and Mineral

            78N-0024

 

16        Misc External

            75N-0176 Request for Data and Information

            75N-0183 Mercury-containing Drug Products for Topical Antimicrobial OTC Human

                             Use

            75N-0183 Alcohol Drug Products for Topical Antimicrobial OTC Human Use

            75N-0183 Diaper Rash

            78N-0021 Astringent Drug Products

            78N-0021 Diaper Rash

            78N-0021 Externally Administered Fever Blister Drug Products

            78N-0021 Insect Bite Neutralizer

            78N-0021 Poison Ivy, Oak, and Sumac Prevention DRUG pRODUCTS

            78N-0065 Skin Bleaching

            78N-0301 Astringent Drug Products

            78N-0301 Diaper Rash

            78N-0301 Externally Administered Fever Blister Drug Products

            78N-0301 Insect Bite Neutralizer

            78N-0301 Male Genital Desensitizing

            78N-0301 Poison Ivy, Oak, and Sumac Prevention Drug Products

            80N-0146 Nailbiting and Thumbsucking Deterrent

            80N-0227 Camphorated Oil

            80N-0238 Wart Remover

            80N-0348 Ingrown Toenail

            80N-0357 Hair Grower and Sebum Hair Loss

            80N-0476 Diaper Rash

            81N-0122 Corn and Callus Remover

            81N-0144 Topically Applied Hormone-containing Drug Products

            82N-0054 Boil Ointment

            82N-0214 Dandruff, Seborrheic Dermatitis and Psoriasis

 

17        Misc Internal

            75N-0176 Request for Data and Information

            77N-0094 Quinine for Treatment of Nocturnal Leg Muscle Cramps

            79N-0176 Stomach Acidifiers

            79N-0177 Sweet Spirits of Nitre

            79N-0368 Cholecystokinetic Drugs

            79N-0378 Anthelmintic Drugs

            79N-0379 Exocrine Pancreatic Insufficiency Drugs

            80N-0395 Hypophospatemia and Hyperphosphatemia Drug Products

            80N-0419 Aphrodisiac Drug Products

            81N-0022 Weight Control

            81N-0027 Smoking Deterrent

            81N-0040 Insect Repellent

            81N-0050 Acute Toxic Ingestion

            81N-0060 Orally Administered Treatment for Fever Blisters

            81N-0064 Deodorant Drug Products for Internal Use

            81N-0106 Digestive Aid

            82N-0165 Menstrual Drug Products

            82N-0166 Overindulgence in Alcohol & Food

            82N-0168 Benign Prostatic Hypertrophy

 

18        Stimulants

            75N-0244

 

19        Tropical Antibiotics (Antimicrobial II)

            76N-0482

 

           

           

ACTION COMPLETED ON THE COMMENT FILES

 

TITLE                                                                                     CFR PART NO.

 

01        Antacid & Antiflatulent                                             331 & 332

            75N-0357

 

05        Sleep-Aids                                                      310.519

            75n-0244 Daytime Sleep-Aids

 

14        Antiperspirnat                                                             310.510

            75N-0003 Zirconium

 

15        Vitamin and Mineral                                                   Withdrawn

            78N-0024

 

16        Misc External                                                              310.526

            80N-0227 Camphorated Oil

 

17        Misc Internal                                                               310.525

            79N-0177 Sweet Spirits of Nitre                                357

            79N-0368 Cholecystokinetic Drugs

 

 

 

 

 

                                                O-T-C ANTACID DATA SUBMISSIONS

 

VOLUME #	COMPANY	PRODUCTS
01	Plough Inc.	Dl-Gel liquid tablets
02	Smith, Miller, & Parch Inc.	Alzinex tablets magma
03	American Cyannaid Co.	Aciban Antacid tablets
04/05	Ayerst Laboratories Inc.	Riopan susp. Chew tablets
06	Whitehall Labs	Bisodol tablets powder Bisodol plus with Belladonne plus tablets
07/08	A.H. Robins Co.	Silain tablets Silain-gel tablets liquid
09	A.H. Robins Co.	Robalate liquid tablets
10	Lewis Howe Co.	Tums liquid
11	Arch Labs	Dicarbosil No. 2 Liquid
12	Lewis Howe Co.	Milk of Magnesia
13 & 52	Wyeth Lab.	A-M-T susp. Aludrox susp. Tablets        Amphojel susp w/ mineral oil            tablets, 300 mg. susp.         0.6 gm. tablets Basaljel Phosphaljel
14	Riker	Titralac tablets              liquid              tablets for Military
15	Sterling Drug	Aluminum Hydroxide
16	Sterling Drug