NDC 0295-9116

Adult Acnomel Tinted

Resorcinol 2% Sulfur 8%

Adult Acnomel Tinted is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Denison Pharmaceuticals, Inc.. The primary component is Resorcinol; Sulfur.

Product ID0295-9116_7acae2ea-c040-6dca-e053-2991aa0a68b3
NDC0295-9116
Product TypeHuman Otc Drug
Proprietary NameAdult Acnomel Tinted
Generic NameResorcinol 2% Sulfur 8%
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2017-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333D
Labeler NameDenison Pharmaceuticals, Inc.
Substance NameRESORCINOL; SULFUR
Active Ingredient Strength2 g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0295-9116-01

7 g in 1 PACKAGE (0295-9116-01)
Marketing Start Date2017-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0295-9116-09 [00295911609]

Adult Acnomel Tinted CREAM
Marketing CategoryOTC monograph final
Application Numberpart333D
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-01

NDC 0295-9116-01 [00295911601]

Adult Acnomel Tinted CREAM
Marketing CategoryOTC monograph final
Application Numberpart333D
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-01

Drug Details

Active Ingredients

IngredientStrength
RESORCINOL2 g/100g

OpenFDA Data

SPL SET ID:2b916d22-9146-4307-a3cc-fae41e64c396
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312793
  • 209990

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