Label: BUTT AND THIGHS ACNE TREATMENT- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

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 October 13, 2022

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  • ACTIVE INGREDIENT

    Salicylic Acid 2%

  • PURPOSE

    Purpose: Acne treatment

  • USE:

    For the treatment of acne.

  • WARNINGS

    For external use only.

  • WHEN USING

    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.

  • DIRECTIONS:

    Clean the skin thoroughly before applying product.
    Cover the entire affected area with a thin layer one to three times daily.
    Because excess 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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • SAFE HANDLING WARNING

    Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Aqua, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Glycerin, Polyglyceryl-6 Palmitate/Succinate, Cetearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cetyl Alcohol, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Organic Butyrospermum Parkii (Shea) Butter, Dimethicone, Dimethicone Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Parfum, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate, Mentha Piperita (Peppermint) Oil, Salix Alba Bark Extract, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hexyl Cinnamal, D-Limonene, Linalool, Benzyl Salicylate, Benzyl Alcohol, Citral.

  • BUTT & THIGHS ACNE TREATMENT CREAM 4oz (Label - Box)

    BUTT & THIGHS 4oz

  • INGREDIENTS AND APPEARANCE
    BUTT AND THIGHS  ACNE TREATMENT
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82767-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LAURETH-7 (UNII: Z95S6G8201)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ROSEMARY (UNII: IJ67X351P9)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRAL (UNII: T7EU0O9VPP)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82767-002-04118.3 mL in 1 TUBE; Type 0: Not a Combination Product09/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00609/22/2022
    Labeler - Teamtrade Inc. (067321781)