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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC External Analgesic Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC External Analgesic Drug Products
  
  	
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    Print**Final Monograph (****21 CFR part 348****):**External Analgesic Drug Products for Over-the-Counter Human UseOTC External Analgesic Drug Products found on this page:Original Active Ingredients and LabelingCorticosteroidsDiaper RashDiphenhydramineFever Blister and Cold Sore*Aloe Vera* and UreaVaginal Douche ProductsMale Genital DesensitizersPatches, Plasters and PoulticesPoison Ivy, Oak, Sumac and Insect BitesInsect RepellentNonmonograph Ingredients**External Analgesic Drug Products: Original Active Ingredients and Labeling**Advance Notice Of Proposed RulemakingDate*FR* CitationAdvance Notice of Proposed Rulemaking12/4/197944FR69768Correction2/5/198045FR7820Correction3/25/198045FR19265Reopening of Administrative Record: Panel recommends 2.5%>9/26/198045FR63878Extension of Comment Period12/28/198247FR57738Proposed RuleDate*FR* CitationTentative Final Monograph2/8/198348FR5852Correction3/11/198348FR10373**External Analgesic Drug Products: Corticosteroids**Proposed RuleDate*FR* CitationTentative Final Monograph2/8/198348FR5852Proposed Rule: Adds seborrheic dermatitis/psoriasis indication for hydrocortisone7/30/198651FR27360Proposed Rule: Adds anal and genital itch indication for hydrocortisone8/25/198853FR32592Proposed Rule: Increases hydrocortisone concentration from 0.25% to 1%2/27/199055FR6932Notice of Enforcement: Allows marketing of 1% hydrocortisone8/30/199156FR43025Notice: Advisory Committee meeting on topical corticosteroid safety2/17/200570FR8104**External Analgesic Drug Products: Diaper Rash**Advance Notice Of Proposed RulemakingDate*FR* CitationReopening of Administrative Record9/7/198247FR39412Correction12/7/198247FR54982Proposed RuleDate*FR* CitationProposed Rule: Classifies diaper rash indication as nonmonograph6/20/199055FR25234Final RuleDate*FR* CitationFinal Rule12/18/199257FR60426**External Analgesic Drug Products: Diphenhydramine**Proposed RuleDate*FR* CitationProposed Rule: Adds warnings and directions8/29/199762FR45767**External Analgesic Drug Products: Fever Blister and Cold Sore**Advance Notice Of Proposed RulemakingDate*FR* CitationAdvance Notice Of Proposed Rulemaking9/7/198247FR39412Correction12/7/198247FR54982Proposed RuleDate*FR* CitationProposed Rule: Adds fever blister and cold sore indication1/31/199055FR3370Correction3/27/199055FR11291**External Analgesic Drug Products: *Aloe Vera* and Urea**Advance Notice Of Proposed RulemakingDate*FR* CitationRequest for Data12/31/200368FR75585**External Analgesic Drug Products: Vaginal Douche**Advance Notice Of Proposed RulemakingDate*FR* CitationReopening of Administrative Record11/19/199762FR61710**External Analgesic Drug Products: Male Genital Desensitizers**Proposed RuleDate*FR* CitationProposed Rule: Adds indication for benzocaine and lidocaine10/2/198550FR40260Final RuleDate*FR* CitationFinal Rule6/19/199257FR27654**External Analgesic Drug Products: Patches, Plasters, and Poultices**Proposed RuleDate*FR* CitationProposed Rule: Classifies dosage forms as category III7/17/200368FR42324****External Analgesic Drug Products: Poison Ivy, Oak, Sumac and Insect Bites****Advance Notice Of Proposed RulemakingDate*FR* CitationReopening of Administrative Record9/7/198247FR39412Correction12/7/198247FR54982Proposed RuleDate*FR* CitationProposed Rule: Adds poison ivy, oak, sumac and insect bite indications10/3/198954FR40818**External Analgesic Drug Products: Insect Repellent**Advance Notice Of Proposed RulemakingDate*FR* CitationRequest for Data2/22/200772FR7941**External Analgesic Drug Products: Nonmonograph Ingredients**Proposed RuleDate*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434Correction6/7/199055FR23235Proposed Rule: Classifies category II and III ingredients without data as non-monograph8/25/199257FR38568Correction9/8/199257FR40944Correction11/9/199257FR53300Proposed Rule: 60+ Drug Categories6/19/200873FR34895Final RuleDate*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914Correction12/3/199055FR49973Technical Amendment: Corrects an ingredient name1/30/199257FR3526Technical Amendment: Correct an ingredient name10/1/199257FR45295Final Rule: Classifies category II and III ingredients without data as nonmonograph5/10/199358FR27636Back to Top

                                                                                  Content current as of:
      03/31/2017Historical Status of OTC Rulemakings
 
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