Label: 2HEALTH 4EVER HAND SANITIZER- alcohol gel

  • 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 November 2, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 70% v/v

    Purposes

    Antimicrobial

  • Uses

    • Help reduce bacteria and virus which could cause disease 
    • Recommended for repeated use
  • Warnings

    Flammable. Keep away from fire or flame.
    For External Use Only.

    When using this product,

    Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use & ask a doctor if

    Irritation or rash appears and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Put enough product in your palm to cover your hands and rub hands 
    • Together briskly until dry. 
    • Children under 6 years should be supervised when using this product.
  • Other information

    • Store below 110°F (43°C)
  • Inactive ingredients

    Carbopol, Glycerin, Triethanolamine, Water, Citrics Fragrance.

  • Question or comments???

    +1 (956) 332-10-44

  • Package Labeling:250ml

    Bottle

  • Package Labeling:500ml

    Bottle2

  • INGREDIENTS AND APPEARANCE
    2HEALTH 4EVER HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80916-000
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80916-000-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2020
    2NDC:80916-000-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/02/2020
    Labeler - Jp Inter Trade, S.A. de C.V. (951583388)
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