Label: EQUALINE- salicylic acid paste

  • 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 24, 2013

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  • ACTIVE INGREDIENT

    SALICYLIC ACID 2.0%

    PURPOSE

    ACNE TREATMENT

  • USES

    FOR THE TREATMENT OF ACNE.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    USE TWICE A DAY. WET FACE. APPLY TO HANDS WITH SOME WATER AND WORK INTO LATHER. GENTLY MASSAGE FACE AND RINSE THOROUGHLY.

  • INACTIVE INGREDIENTS:

    WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, GLYCERIN, COCAMIDOPROPYL BETAINE, OXIDIZED POLYETHYLENE, ACRYLATES CROSSPOLYMER-4, CHONDRUS CRISPUS (CARRAGEENAN), C12-15 ALKYL LACTATE, DISODIUM EDTA, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, CITRUS GRANDIS (GRAPEFRUIT) FRUIT EXTRACT, POLYQUATERNIUM-7, CAMELLIA SINENSIS LEAF EXTRACT, ASCORBYL PALMITATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, ANTHEMIS NOBILIS FLOWER EXTRACT, POLYSORBATE 20, POLYVINYL ALCOHOL, PROPYLENE GLYCOL, SODIUM CHLORIDE, BENZALKONIUM CHLORIDE, BUTYLENE GLYCOL, SODIUM BENZOTRIAZOYL BUTYLPHENOL SULFONATE, AGAR, ALUMINA, MICA, TITANIUM DIOXIDE, SODIUM HYDROXIDE, RED 30 (73360), RED 40 (CI 16035), EXT. VIOLET 2 (CI 60730), FRAGRANCE (PARFUM). 

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    EQUALINE 
    salicylic acid paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-828
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PUMMELO (UNII: ET1TN5W71X)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
    AGAR (UNII: 89T13OHQ2B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-828-04124 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/17/2013
    Labeler - SUPERVALU INC. (006961411)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41163-828)
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