Label: ALH 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 July 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on the skin when water, soap & towel are not available – Recommended for repeated use.

  • Warnings

    For external use only.

    Flammable — Keep away from fire or flame.

    When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not use on broken or irritated skin.

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

    Keep out of reach of children.

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

  • Directions

    Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

  • Other information

    • Do not store above 105 °F (40 °C).
    • May discolor certain wood surfaces.
  • Inactive Ingredients

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice.

  • Questions?

    Call +1 716-256-3240

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Advanced Local Health LLC, Doral, Florida, 33166

  • PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label

    HAND
    SANITIZER

    CONTAINS
    70%
    ETHYL
    ALCOHOL

    TOPICAL
    SOLUTION

    WITH
    ALOE VERA

    6.7 Fl. Oz. (200 ml)

    PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALH HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74264-001
    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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    trolamine (UNII: 9O3K93S3TK)  
    glycerin (UNII: PDC6A3C0OX)  
    propylene glycol (UNII: 6DC9Q167V3)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74264-001-01200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
    2NDC:74264-001-02415 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/2020
    3NDC:74264-001-0360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    4NDC:74264-001-04240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A04/01/2020
    Labeler - Advanced Local Health LLC (117466501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Absara Cosmetics S.A.P.I DE CV816161236MANUFACTURE(74264-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biu Lab S.A de C.V951576593MANUFACTURE(74264-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Desarrollo Tecnológico Laser S.A. de C.V.812928638MANUFACTURE(74264-001)
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