ACNE OFF ACNE TREATMENT FACIAL- salicylic acid lotion 
Armand Dupree

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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Acne Off Acne Treatment Facial Lotion

Drug Facts


Active Ingredient

Salicylic Acid (1.86%)

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

Benzalkonium chloride,Benzoic acid, Camphor, Clove oil, Ethyl alcohol, Eucalyptus oil, Peppermint oil, Water.

Acne OFF  Acne Treatment Facial Lotion SALICYLIC ACID 1.86% Penetrates pores to control acne pimples and blackheads  CONT. NET. 120 ml 4.05 FL.OZ. Dist. in the U.S.A. by: ARMAND DUPREE, Inc., 14901 S.Orange Blossom Trail, Orlando, FL 32837 Country of Origin: MEXICO  LOT NO.  EXP.DATE

Acne Off Acne Treatment Facial Lotion 120ml (10849-004-01)


ACNE OFF Lotion Inner



ACNE OFF Lotion Outer

ACNE OFF ACNE TREATMENT FACIAL 
salicylic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10849-004
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 18.6 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CLOVE OIL (UNII: 578389D6D0)  
ALCOHOL (UNII: 3K9958V90M)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10849-004-01 1 in 1 CARTON
1 120 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 04/19/2012 09/08/2015
Labeler - Armand Dupree (013966604)
Establishment
Name Address ID/FEI Business Operations
Laboratorios Kener S.A. de C.V. 810347658 manufacture(10849-004)

Revised: 9/2015
Armand Dupree