Label: HAND SANITIZER GEL- ethyl alcohol gel

  • NDC Code(s): 77975-025-01
  • Packager: Guangzhou Tingcai Cosmetic Co., Ltd.
  • 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 September 14, 2023

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  • Active ingredient

    ETHYL ALCOHOL 62%

  • Purpose

  • Use

    to decrease bacteria and germs on the skin ,recommended for repeated use

  • Warnings

    for external use only-hands.flammable .keep away from heat and flame

    Keep out of reach of children.

    in case of accidental ingestion,seek professional assistance or contact a poison control center immediately.

    Stop use and ask a doctor

    if skin irritation develops.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

    For children under 6, use only under adult supervision.

    Not recommended for infants.

  • Other Information

    Do not store above 105 ℉

    May discolor some fabrics

    Harmful to wood finishes and plastics

    When using this product:

    Keep out of eyes.

    In case of contact with eyes, flush thoroughly with water.

    Do not inhale or ingest.
    Avoid contact with broken skin.

  • Inactive ingredients

    Water(Aqua),Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-40 Hydrogenated castor Oil

  • Packaging

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77975-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77975-025-01100 in 1 CARTON09/14/2023
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/14/2023
    Labeler - Guangzhou Tingcai Cosmetic Co., Ltd. (529562889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Tingcai Cosmetic Co., Ltd.529562889manufacture(77975-025)
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