Label: FAMILY CARE ULTRA ACNE TREATMENT- salicylic acid gel

  • 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 17, 2017

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

  • ACTIVE INGREDIENT

    Active ingredient                                                         Purpose

    Salicylic acid 2%.........................................................Acne medication

  • PURPOSE

    Uses

    for the treatment of acne

  • WARNINGS

    Warnings

    For external use only

    Flammable keep away from extreme heat or open flame

  • WHEN USING

    When using this product

    • avoid contact with the eyes. If product gets into the eyse rinse thoroughly with water
    • with 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 acne medication should be used unless directed by your doctor
    • limit use to the face and neck
  • STOP USE

    Stop use and ask a doctor if skin or eye irritation develops

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    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 the skin may occur, start with one application daily, then gradually increase to 2 or 3 applications daily if needed

    or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a dy or every other day

  • STORAGE AND HANDLING

    Other informatiom

    store in a cool dry place

  • INACTIVE INGREDIENT

    Inactive ingredients ethanol, water, glycerin, sorbitol, polysorbate 20, hydroxyethyl cellulose, decolorized alove vera leaf, helichrysum italicum flover, L-menthol, sodium hydroxide, fragrance, methylparaben, edetate disodium, propylparaben

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 U.S.A.

    www.ueccorp.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ULTRA ACNE TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-587-121 in 1 BOX02/17/2017
    111.9 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/17/2017
    Labeler - United Exchange Corp. (840130579)