Label: GET-BACK - TARGETED BODY ACNE- salicylic acid spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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

  • Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

    Purpose

    Acne treatment

  • Uses

    • For the treatment of acne

  • Warnings

    For external use only.

    Keep out of reach of children.

    • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. • Do not get into eyes. tt excessive skin irritation develops or increases, discontinue use and consult a doctor. • If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Hold the tube with the nozzle facing down. • Spray an even layer directly to back acne. • Let it dry before getting dressed. • Use twice a day for best results.

  • Inactive Ingredients:

    Water, Propanediol, Glycerin, Salix Alba (Willow) Bark Extract, Niacinamide, Rosmarinus Officinalis (Rosemary) Extract, Glycyrrhiza Glabra (Licorice) Root Extract. Citrus Limon (Lemon) Peel Extract, Citrus Grandis (Grapefruit) Seed Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Epilobium Fleischeri Flower/Leaf/Stem Extract, Panthenol, Tocopherol, Aloe Barbadensis Leaf Juice, PPG-1-PEG-9 Lauryl Glycol Ether, Coceth-7, Polydextrose, Dextrin, Amylopectin, PEG-40 Hydrogenated Castor Oil, Parfum (Fragrance), Zinc PCA, Ethylhexylglycerin,  Phenoxyethanol, Chlorphenesin, Sodium Hydroxide, Citric Acid, Coumarin.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Question or Comments:

    1-800-253-1983

  • Package Labeling:

    012

  • INGREDIENTS AND APPEARANCE
    GET-BACK - TARGETED BODY ACNE 
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83010-012
    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)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ROSEMARY (UNII: IJ67X351P9)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LEMON PEEL (UNII: 72O054U628)  
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    COCETH-7 (UNII: 58Y261JLH5)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COUMARIN (UNII: A4VZ22K1WT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83010-012-001 in 1 CARTON01/01/2023
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/01/2023
    Labeler - Maelys Cosmetics, LTD (532018258)