Acne Off Acne Treatment

Dosage form: gel
Ingredients: SALICYLIC ACID 20g in 100g
Labeler: Armand Dupree
NDC Code: 10849-003

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.

Acne Off Acne Treatment Gel

Drug Facts


Active Ingredient

Salicylic Acid (2%)

Purpose

Acne Treatment

Indications
  •  For the treatment of acne.
  • Clears up acne blemishes, acne pimples, blackheads, whiteheads and allows skin to heal.
  • Helps prevent new acne blemishes, acne pimples, blackheads or whiteheads from forming.
  • Helps keep skin clear of new acne blemishes, acne pimples, blackheads or whiteheads.

Warnings
  • For external use only.

When using this product
  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions
  • Clean the skin thoroughly 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 occurs, reduce application to once a day or every other day.

Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days.
If no discomfort occurs, follow the directions stated above.

INACTIVE INGREDIENTS

Butylene glycol, Ethyl alcohol, Glycerin, Hydroxyethylcellulose, Propylene glycol, Sodium citrate, Water.

Acne Off Acne Treatment 20g

Acne OFF Acne Treatment Gel SALICYLIC ACID 2% Penetrates Pores to control acne pimples and blackheads CONT.NET. 20 g, NET WT.0.71 OZ Dist. in the U.S.A by: ARMAND DUPREE, Inc., 14901 S. Orange Blossom Trail, Orlando, FL 32837 Country of Origin: Mexico

Acne Off Acne Treatment Gel 20g (10849-003-01)




ACNE OFF ACNE TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10849-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL 
ALCOHOL 
GLYCERIN 
PROPYLENE GLYCOL 
SODIUM CITRATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:10849-003-011 TUBE (TUBE) in 1 CARTON
120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/19/2012
Labeler - Armand Dupree (013966604)
Establishment
NameAddressID/FEIOperations
Laboratorios Kener S.A. de C.V.810347658manufacture

Revised: 04/2012
 
Armand Dupree

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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