Label: FOH HEALTH ESSENTIALS SANITIZER GEL- hand sanitizer 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 August 25, 2020

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  • Packaging

    FOH Sanitizer Gel 3785ml

    FOH Sanitizer Gel 59ml

    Warnings

    For external use only: hands. 

    FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.
    When using this product ▪ Keep out of eyes. In case of contact with eyes, flush thoroughly with water
    ▪ Avoid contact with broken skin ▪ Do not inhale or ingest ▪ Stop use and ask a doctor if: irritation and
    redness develop or condition persists for more than 72 hours

    Active Ingredient

    Ethyl alcohol 70%

    Purpose

    Antiseptic

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right
    away

    Uses

    To decrease bacteria on the skin that could cause disease ▪ Recommended for repeated use

    Inactive Ingredients

    Deionized Water, Aloe Vera Gel (Aloe Barbadensis Leaf Juice), Carbomer,
    Triethanolamine, Vitamin E (Tocopheryl Acetate).

    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°F ▪ May discolor some fabrics ▪ Harmful to wood finishes and plastics.

    70% ALCOHOL
    Kills 99.99% of Germs
    Aloe Vera & Vitamin E
    Fragrance Free

    *Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

    Distributed by: FOH Inc Miami, FL 33138
    fohhealth.com

    CRUELTY FREE
    VEGAN
    PARABEN FREE
    NO SULFATES
    MADE IN USA

  • INGREDIENTS AND APPEARANCE
    FOH HEALTH ESSENTIALS SANITIZER GEL 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79963-100
    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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79963-100-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
    2NDC:79963-100-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2020
    Labeler - FOH INC (036479023)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prive International Inc058849652manufacture(79963-100)
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