Label: ALOEVERA SOOTHING GEL 98%- 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 March 22, 2019

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

  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    aloe barbadensis leaf extract, alcohol, butylene glycol, etc

  • PURPOSE

    for skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    take a suitable amount on the skin

  • 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
    ALOEVERA SOOTHING GEL 98% 
    aloe, glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0001-1300 mL in 1 JAR; 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(72988-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569label(72988-0001)