ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]

ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]
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NDC 76354-616-01
Set ID 6ab34d5e-4439-4c64-ad0d-6c8641109c38
Category HUMAN OTC DRUG LABEL
Packager J. A. Cosmetics U.S. INC
Generic Name
Product Class
Product Number
Application Number PART358H
  • ACTIVE INGREDIENT

    Active Ingredient:

    Salicylic Acid 1.0 %

  • PURPOSE

    Purpose:

    Acne Treatment

  • INDICATIONS & USAGE

    Uses:

    For the treatment of acne

    Helps prevent new acne blemishes

  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    When Using This Product:

    Keep out of eyes, rinse with water to remove.

    Skin irrittion and dryness is more likely to occur if you use another topical acne medications at the same time.  If irritation occurs, only use one medication at a time.

  • ASK DOCTOR

    Stop use and ask a doctor If

    rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

  • DOSAGE & ADMINISTRATION

    Directions:

    Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of 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.

  • STORAGE AND HANDLING

    Other Information:

    Protect the product in this container from exessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water,  Alcohol Denat, Hamamelis Birginiana (Witch Hazel), Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cinnamomum Camphora (Camphor) Bark oil, Sodium Benzoate, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Camellia Sinensis Leaf Extract, Butylene Glycol, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Ethylhexylglycerin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-616
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-616-016 mL in 1 BOTTLE; Type 0: Not a Combination Product10/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/20/2015
    Labeler - J. A. Cosmetics U.S. INC (186705047)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co., Ltd.544377996manufacture(76354-616)

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