Label: ACNE SHAVE MOISTURIZER- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 25, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Salicylic acid 0.5%.................................Acne medication

  • PURPOSE

    Use

    for the management of acne

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • cleanse the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times if needed or as directed by a doctor
    • if dryness or peeling occurs, reduce application to once a day or every other day
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Dicaprylyl Carbonate, Pentylene Glycol, Cetearyl Alcohol, Dimethicone, Dicetyl Phosphate, Ceteth-10 Phosphate, Aluminum Starch Octenylsuccinate, Melia Azardirachta Seed Oil, Allantoin, Xanthan Gum, Steareth-20, Hydroxyacetophenone, Methyl Gluceth-20, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, 1,2-Hexanediol, Methyl Lactate, Sodium Hydroxide, Disodium EDTA

  • DOSAGE & ADMINISTRATION

    Distributed by:

    17211 Valley View

    Cerritos, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    73112

  • INGREDIENTS AND APPEARANCE
    ACNE SHAVE MOISTURIZER 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    METHYL LACTATE, DL- (UNII: H10S91526X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-112-0398 mL in 1 TUBE; Type 0: Not a Combination Product07/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/25/2017
    Labeler - United Exchange Corp. (840130579)