Label: HYDRO- alcohol 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 July 14, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v ......................Antimicrobial

  • Purpose

    Antimicrobial, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
  • Inactive ingredients

    Water, Triethanolamine, Carbomer, Aloe Vera Extract, Phenoxethynol

  • Package Label - Principal Display Panel

    HYDRO Hand Sanitizer Gel with Aloe

    8.5 OZ (250 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    HYDRO 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77994-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.0003 mL  in 1 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 mL  in 1 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.002 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.4 mL  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.0025 mCi  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77994-100-01250 mL in 1 BOTTLE, PLASTIC; 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 - HYDRO GLOBAL INC (117523372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aloe Laboratories, Inc606458024repack(77994-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemical Solutions de México, S.A. de C.V.813291820manufacture(77994-100)
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