Label: HARMON FACE VALUES OIL-FREE BODY WASH SALICYLIC ACID ACNE TREATMENT PINK GRAPEFRUIT- salicylic acid liquid

  • 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 January 11, 2022

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

  • Active Ingredients

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Uses

    for the treatment of acne.

  • 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. • avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • Keep out of reach of children.

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

  • Directions

    • cover the entire affected area with a thin layer and rinse thoroughly 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
  • Other information

    • may stain some fabrics
  • Inactive Ingredients

    water, sodium C14-16 olefin sulfonate, glycerin, cocamidopropyl betaine, acrylates copolymer, cocamidopropyl PG-dimonium chloride phosphate, polyquaternium-7, citrus grandis (grapefruit) fruit extract, anthemis nobilis flower extract (roman chamomile), camellia sinensis leaf extract (green tea), chondrus crispus powder (carrageenan), agar, neopentyl glycol dicaprylate/dicaparate, sodium ascorbyl phosphate (vitamin C phosphate), propylene glycol, C12-15 alkyl lactate, polysorbate 20, butylene glycol, polyvinyl alcohol, potassium chloride, phenethyl alcohol, PPG-2 methyl ether, disodium EDTA, sodium chloride, sodium hydroxide, benzlkonium chloride, sodium benzotriazolyl butylphenol sulfonate, fragrance, mica, titanium dioxid, iron oxides, red 30, red 40, ext. violet 2

  • Label

    42537E1-F3

  • INGREDIENTS AND APPEARANCE
    HARMON FACE VALUES OIL-FREE BODY WASH SALICYLIC ACID ACNE TREATMENT PINK GRAPEFRUIT 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    PUMMELO (UNII: ET1TN5W71X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    AGAR (UNII: 89T13OHQ2B)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-082-55251 mL in 1 BOTTLE; Type 0: Not a Combination Product03/06/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B03/06/2014
    Labeler - HARMON STORES, INC. (804085293)