Label: ANDYS- alcohol 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 March 29, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% .........................Antimicrobial

    ACTIVE

  • DIRECTIONS AND USD

    USE Hand Sanitizer to help reduce bacteria on the skin

    INDICATION Put enough product in your palm to cover hands and rub hands together briskly until dry

    USE

  • INACTIVE INGREDIENTS

    Carbomer, Triethanolamine Lauryl Sulfate, water

    Inactive

  • WARNING

    Flammable. Keep away from fire or flame. For external use only. When using this product: Don't use in or near the eyes.

    In the case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

    warning

  • Keep Out of Reach of Children.

    Keep Out of Reach of Children. If swallowed, get medical help or contact poison control center right away

    KEEP

  • PURPOSE

    Antimicrobial

    Anti

  • DOSAGE

    USE Hand Sanitizer to help reduce bacteria on the skin

    INDICATION Put enough product in your palm to cover hands and rub hands together briskly until dry

    DOSAGE

  • ANDY's HAND SANITIZER Unscented

    Kills Over 99% of Most Common Germs

    Refill your bottle of Hand Sanitizer in

    * Kitchen * Automobile * Offices* Bathrooms *

    125.11 FL OZ (3.7L)

    Front

  • INGREDIENTS AND APPEARANCE
    ANDYS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73755-110
    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
    WATER O-18 (UNII: 7QV8F8BYNJ) 1 mL  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 1 mL  in 1 mL
    CARBOMER 1342 (UNII: 809Y72KV36) 1 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73755-110-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/21/2020
    Labeler - Brand Name Distributors (078570365)
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