Label: ATOPIM- fermented enxyme extract of aloe. glycerin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 10, 2019

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  • ACTIVE INGREDIENT

    aloe, glycerin

  • INACTIVE INGREDIENT

    butylene glycol, water, niacinamide, adlay fermented extract, etc

  • PURPOSE

    improve on acne, stopic dermatitis, and effects on burn treatment, skin soothing

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    after cleansing thoroughly, moisten 1~2g in cotton or sterilized gauze and attached to the affected area for 20~30 minutes to absorb enough contents

  • WARNINGS

    do not swallow it

    do not use on wounded skin

    do not use allergic skin types

  • DOSAGE & ADMINISTRATION

    for topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ATOPIM 
    fermented enxyme extract of aloe. glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73158-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.5 g  in 100 g
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE64 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73158-0001-1100 g in 1 BOTTLE; Type 0: Not a Combination Product06/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34705/11/2019
    Labeler - HI Technology (695708203)
    Registrant - The Times Co., Ltd. (695708203)
    Establishment
    NameAddressID/FEIBusiness Operations
    HI Technology695708203manufacture(73158-0001)
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