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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 Skin Protectant Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Skin Protectant Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 347):*Skin Protectant Drug Products for Over-the-Counter Human Use*

OTC Skin Protectant Drug Products found on this page:

Original Active Ingredients and Labeling
	Astringent
	Diaper Rash
	Fever Blister and Cold Sore
	Nonnonograph Ingredients
	Poison Ivy, Oak, Sumac and Insect Bites**Skin Protectant Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			8/4/1978
			43FR34628Correction
			9/19/1978
			43FR42018Reopening of Administrative Record
			3/21/1980
			45FR18402Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			2/15/1983
			48FR6820Correction
			4/12/1983
			48FR15655Reopening of Administrative Record: To include "hard fat"
			12/19/1991
			56FR65873Final Rule
			Date
			*FR* CitationFinal Monograph
			6/4/2003
			68FR33362Technical Amendment: Corrects indications
			12/9/2003
			68FR68509Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545
			8/19/2004
			69FR51362Technical Amendment: Lip protectant labeling
			2/1/2008
			73FR6014Availability of Guidance (Labeling)
			8/4/2008
			73FR45227

**Skin Protectant Drug Products: Astringent**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			9/7/1982
			47FR39436Correction
			10/15/1982
			47FR46117Proposed Rule
			Date
			*FR* CitationProposed Rule
			4/3/1989
			54FR13490Correction
			4/27/1989
			54FR18197Proposed Rule: Revises labeling to be consistent with 6/4/2003 final monograph
			6/13/2003
			68FR35346Final Rule
			Date
			*FR* CitationFinal Rule
			10/21/1993
			58FR54458Final Rule: Revises "Hamamelis water" to "witch hazel"
			6/3/1994
			59FR28767Direct Final Rule: Revises labeling to be consistent with 6/4/2003 final monograph
			6/13/2003
			68FR35290Confirmation of effective date
			10/9/2003
			68FR58273Correction
			1/22/2004
			69FR3005Technical Amendment: Astringents producing aluminum acetate
			3/6/2009
			74FR9759

**Skin Protectant Drug Products: Diaper Rash**

Advance Notice Of Proposed Rulemaking
			Date
			*FR*CitationReopening of Administrative Record
			9/7/1982
			47FR39436Correction
			10/15/1982
			47FR46117Proposed Rule
			Date
			*FR* CitationProposed Rule
			6/20/1990
			55FR25204Extension of Comment Period: Vitamins A and D
			12/18/1990
			55FR51926Final Rule
			Date
			*FR* CitationFinal Monograph
			6/4/2003
			68FR33362Technical Amendment: Corrects indications
			12/9/2003
			68FR68509Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545
			8/19/2004
			69FR51362

**Skin Protectant Drug Products: Fever Blister and Cold Sore**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationReopening of Administrative Record
			9/7/1982
			47FR39436Correction
			10/15/1982
			47FR46117Proposed Rule
			Date
			*FR* CitationProposed Rule: Skin Protectants; External Analgesics for Fever Blister and Cold Sore Treatment
			1/31/1990
			55FR3362Correction
			3/27/1990
			55FR11291Final Rule
			Date
			*FR* CitationFinal Monograph
			6/4/2003
			68FR33362Technical Amendment: Corrects indications
			12/9/2003
			68FR68509Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545
			8/19/2004
			69FR51362

**Skin Protectant Drug Products: Nonmonograph Ingredients**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			5/16/1990
			55FR20434Correction
			6/7/1990
			55FR23235Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
			8/25/1992
			57FR38568Correction
			9/8/1992
			57FR40944Technical Amendment: Correct an ingredient name
			10/1/1992
			57FR45295Correction
			11/9/1992
			57FR53300Proposed Rule: 60+ Drug Categories
			6/19/2008
			73FR34895Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			11/7/1990
			55FR46914Correction
			12/3/1990
			55FR49973Technical Amendment: Corrects an ingredient name
			1/30/1992
			57FR3526Final Rule: Classifies category II and III ingredients without data as nonmonograph
			5/10/1993
			58FR27636

**Skin Protectant Drug Products: Poison Ivy, Oak, Sumac and Insect Bites**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationReopening of Administrative Record
			9/7/1982
			47FR39436Correction
			10/15/1982
			47FR46117Proposed Rule
			Date
			*FR* CitationProposed Rule
			10/3/1989
			55FR40808Final Rule
			Date
			*FR* CitationFinal Monograph
			6/4/2003
			68FR33362Technical Amendment: Corrects indications
			12/9/2003
			68FR68509Technical Amendment: Corrects "approved as of date" in 21 CFR 310.545
			8/19/2004
			69FR51362

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                                                                                  Content current as of:
      01/12/2018Historical Status of OTC Rulemakings
 
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