Label: YOURGOODSKIN RAPID RESCUE TREATMENT- salicylic acid gel

  • NDC Code(s): 68472-237-29, 68472-237-30
  • Packager: BOOTS RETAIL USA INC
  • 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 February 1, 2018

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  • Active ingredients

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of Acne
  • Warnings

    For external use only

  • WHEN USING

    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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • GENERAL PRECAUTIONS

    Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • SAFE HANDLING WARNING

    Flammable. Keep away from extreme heat or open flame.

  • Directions

    • Clean the skin thoroughly before applying the product.
    • Cover the entire affected area with a thin layer 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

    • Avoid storing at extreme temperatures (below 40ºF and above 100ºF).
    • Do not apply to irritated or broken skin.
  • Inactive Ingredients

    Aqua (Water), Alcohol Denat., Polysorbate 20, Dehydroxanthan Gum, Ammonium Glycyrrhizate, Panthenol, Ammonium Hydroxide, Bisabolol, Tetrasodium EDTA, Camellia Sinensis Leaf Extract, Hexylene Glycol

  • QUESTIONS

    USA: Questions? 1-866-752-6687

  • PRINCIPAL DISPLAY PANEL

    YourGoodSkin™

    Rapid Rescue Treatment

    Acne Clearing

    15 ml 0.5 US Fl. Oz.

    Representative Image

  • INGREDIENTS AND APPEARANCE
    YOURGOODSKIN  RAPID RESCUE TREATMENT
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68472-237
    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
    ALCOHOL (UNII: 3K9958V90M)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    AMMONIA (UNII: 5138Q19F1X)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68472-237-301 in 1 CARTON12/19/2017
    1NDC:68472-237-2915 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/19/2017
    Labeler - BOOTS RETAIL USA INC (143151533)
    Registrant - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(68472-237)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth, Inc.080086802manufacture(68472-237)
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