ADULT ACNOMEL TINTED- resorcinol 2% sulfur 8% cream 
Denison Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Adult Acnomel (Tinted)

ACTIVE INGREDIENT

Active ingredients..............................Purpose

Resorcinol 2% .....................................Acne Treatment ointment

Sulfur 8 % ........................................... Acne Treatment

DOSAGE

cover the entire affected area with a thin layer one to three times daily.

Uses

  • for the treatment of acne
  • clears up most acne pimples
  • helps prevent new acne pimples

For external use only

Do not use on:

  • broken skin
  • large areas of the body

When using this product

  • Apply only to areas with acne
  • Rinse right away with water it it gets in eyes
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.

Stop use and ask doctor if

skin irritation occurs or gets worse

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the skin throughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occur, reduce application to once a day or every other day

Other Information

  • store at controlled room temperature (59° - 86°F)

Inactive Ingredients

alcohol 15% (w/w), bentonite, carpobol, fragrance, iron oxides, octoxynol-9, potassium hydroxide, propylene glycol, titanium dioxide, water

Label

Label Image

ADULT ACNOMEL TINTED 
resorcinol 2% sulfur 8% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 g  in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BENTONITE (UNII: A3N5ZCN45C)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9116-017 g in 1 PACKAGE; Type 0: Not a Combination Product01/01/2017
2NDC:0295-9116-0936 g in 1 PACKAGE; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/201703/16/2022
Labeler - Denison Pharmaceuticals, Inc. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208manufacture(0295-9116)

Revised: 3/2022
 
Denison Pharmaceuticals, Inc.