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Drugs

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Rulemaking History for OTC External Analgesic Drug Products

Final Monograph (21 CFR part 348):
External Analgesic Drug Products for Over-the-Counter Human Use

OTC External Analgesic Drug Products found on this page:

Original Active Ingredients and Labeling
Corticosteroids
Diaper Rash
Diphenhydramine
Fever Blister and Cold Sore
Aloe Vera and Urea
Vaginal Douche Products
Male Genital Desensitizers
Patches, Plasters and Poultices
Poison Ivy, Oak, Sumac and Insect Bites
Insect Repellent
Nonmonograph Ingredients

**External Analgesic Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking [PDF]	12/4/1979	44FR69768
Correction [PDF]	2/5/1980	45FR7820
Correction [PDF]	3/25/1980	45FR19265
Reopening of Administrative Record: Panel recommends <2.5% camphor [PDF]	9/26/1980	45FR63878
Extension of Comment Period [PDF]	12/28/1982	47FR57738
Proposed Rule	Date	FR Citation
Tentative Final Monograph [PDF]	2/8/1983	48FR5852
Correction [PDF]	3/11/1983	48FR10373

**External Analgesic Drug Products: Corticosteroids**
Proposed Rule	Date	FR Citation
Tentative Final Monograph [PDF]	2/8/1983	48FR5852
Proposed Rule: Adds seborrheic dermatitis/psoriasis indication for hydrocortisone [PDF]	7/30/1986	51FR27360
Proposed Rule: Adds anal and genital itch indication for hydrocortisone [PDF]	8/25/1988	53FR32592
Proposed Rule: Increases hydrocortisone concentration from 0.25% to 1% [PDF]	2/27/1990	55FR6932
Notice of Enforcement: Allows marketing of 1% hydrocortisone [PDF]	8/30/1991	56FR43025
Notice: Advisory Committee meeting on topical corticosteroid safety [PDF]	2/17/2005	70FR8104

**External Analgesic Drug Products: Diaper Rash**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record [PDF]	9/7/1982	47FR39412
Correction [PDF]	12/7/1982	47FR54982
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies diaper rash indication as nonmonograph [PDF]	6/20/1990	55FR25234
Final Rule	Date	FR Citation
Final Rule [PDF]	12/18/1992	57FR60426

**External Analgesic Drug Products: Diphenhydramine**
Proposed Rule	Date	FR Citation
Proposed Rule: Adds warnings and directions [PDF]	8/29/1997	62FR45767

**External Analgesic Drug Products: Fever Blister and Cold Sore**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice Of Proposed Rulemaking [PDF]	9/7/1982	47FR39412
Correction [PDF]	12/7/1982	47FR54982
Proposed Rule	Date	FR Citation
Proposed Rule: Adds fever blister and cold sore indication [PDF]	1/31/1990	55FR3370
Correction [PDF]	3/27/1990	55FR11291

**External Analgesic Drug Products: *Aloe Vera* and Urea**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data [PDF]	12/31/2003	68FR75585

**External Analgesic Drug Products: Vaginal Douche**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record [PDF]	11/19/1997	62FR61709

**External Analgesic Drug Products: Male Genital Desensitizers**
Proposed Rule	Date	FR Citation
Proposed Rule: Adds indication for benzocaine and lidocaine [PDF]	10/2/1985	50FR40260
Final Rule	Date	FR Citation
Final Rule [PDF]	6/19/1992	57FR27654

**External Analgesic Drug Products: Patches, Plasters, and Poultices**
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies dosage forms as category III [PDF]	7/17/2003	68FR42324

**External Analgesic Drug Products: Poison Ivy, Oak, Sumac and Insect Bites**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record [PDF]	9/7/1982	47FR39412
Correction [PDF]	12/7/1982	47FR54982
Proposed Rule	Date	FR Citation
Proposed Rule: Adds poison ivy, oak, sumac and insect bite indications [PDF]	10/3/1989	54FR40818

**External Analgesic Drug Products: Insect Repellent**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data [PDF]	2/22/2007	72FR7941

**External Analgesic Drug Products: Nonmonograph Ingredients**
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]	5/16/1990	55FR20434
Correction [PDF]	6/7/1990	55FR23235
Proposed Rule: Classifies category II and III ingredients without data as non-monograph [PDF]	8/25/1992	57FR38568
Correction [PDF]	9/8/1992	57FR40944
Technical Amendment: Correct an ingredient name [PDF]	10/1/1992	57FR45295
Correction [PDF]	11/9/1992	57FR53300
Proposed Rule: 60+ Drug Categories [PDF]	6/19/2008	73FR34895
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]	11/7/1990	55FR46914
Correction [PDF]	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name [PDF]	1/30/1992	57FR3526
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]	5/10/1993	58FR27636

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