Adult acnomel tinted cream

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

Warnings section

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 - 86F)

Inactive ingredients

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

Ingredients and appearance - Product information

Adult acnomel tinted cream- Resorcinol 2% sulfur 8%

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0295-9116
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Resorcinol ( UNII: YUL4LO94HK)( Resorcinol - UNII: YUL4LO94HK ) 2 gin 100 g
Sulfur ( UNII: 70FD1KFU70)( Sulfur - UNII: 70FD1KFU70 ) 8 gin 100 g

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0295-9116-01 7g in 1 PACKAGE 2017/01/01
2 NDC: 0295-9116-09 36g in 1 PACKAGE 2017/01/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part333D USA 2017/01/01

Labeler - Denison Pharmaceuticals, Inc.( 001207208)

Establishment

Name ID/FEI Business Operations
Denison Pharmaceuticals, Inc. 001207208 manufacture( 0295-9116)

Package label.principal display panel

Label