Label: AMULDY KIDS- glycerin gel

  • 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 March 23, 2019

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    WATER, ALCOHOL, BUTYLENE GLYCOL, ETC

  • PURPOSE

    for skin protectant

    relieve itchiness by providing moisture and nutrients to the dry skin

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    shake the container for 2 to 3 times before use, apply it evenly

  • WARNINGS

    ■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist

    red specks, swelling, itching

    ■ don’t use on the part where there is injury, eczema, or dermatitis

    Keep out of reach of children

    ■ if swallowed, get medical help or contact a person control center immediately

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    AMULDY KIDS 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0003-125 g in 1 TUBE; Type 0: Not a Combination Product03/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34703/23/2019
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aloe Vera Korea Co.,Ltd.687773350manufacture(72988-0003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569label(72988-0003)
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