Label: TEAM HAND SANITIZER 75% ALCOHOL MOISTURIZING GEL WITH VITAMIN E- 75% alcohol moisturizing gel with vitamin e 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 4, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic.

  • Uses

    • hand sanitizer to help decrease bacteria on skin
    • when water, soap & towel are not available

    recommended for repeated use

  • Warnings

    For external use only: hands.

    Flammable. Keep away from fire or flame.

  • Do not use

    Do not apply around eyes.

    Do not use in ears & mouth.

  • WHEN USING

    When using this product, avoid contact with eyes.

    In case of contact, flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • 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

    • Store between 59 - 86℉ (15 - 30℃)
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    Water, Glycerin, Propylene glycol, Carbomer, Triethanolamine.

  • Package Label - Principal Display Panel

    500-1

  • INGREDIENTS AND APPEARANCE
    TEAM HAND SANITIZER 75% ALCOHOL MOISTURIZING GEL WITH VITAMIN E 
    75% alcohol moisturizing gel with vitamin e gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54708-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54708-101-08500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/03/2020
    Labeler - Venus Skin & Hair Laboratory Ltd. (547075720)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Venus Skin & Hair Laboratory Ltd.547075720manufacture(54708-101) , label(54708-101)
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