Label: DR HYDROCEL NATURAL PURE GEL- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

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 1, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    Water
    Glycerin
    Carbomer
    Lemon Oil
    Tromethamine
    Aloe Extract (09)
    Rosemary Extract
    Green Tea Extract
    Grapefruit Extract
    Tea tree oil

  • PURPOSE

    Sterilization of hands and skin

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

    Supervise children in the use of this product.

  • WARNINGS

    ■ Flammable. Keep away from fire or flame.

    ■ For external use only.

    ■ Do not use in eyes.

    ■ lf swallowed, get medical help promptly.

    ■ Stop use, ask doctor lf irritation occurs.

    ■ Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DR HYDROCEL NATURAL PURE GEL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75332-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LEMON OIL (UNII: I9GRO824LL)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75332-0006-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - MEDICELL CO.,LTD (688731040)
    Registrant - MEDICELL CO.,LTD (688731040)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDICELL CO.,LTD688731040manufacture(75332-0006)
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