Label: WARNER FRIENDS MOISTURIZING HAND SANITIZER APPLE- 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 December 10, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • DRUG FACTS

  • Active Ingredient

    Ethylalcohol 62%...

    Purpose

    Antimicrobial

  • Uses

    Reduces bacteria on hands.

  • Warnings

    Flammable. Keep away from source of ignition or flame.

    For external use only.

    Do not use

    on open skin wound.

    When using this product

    keep out of eyes.

    Stop use and ask a doctor 

    if irritation or redness develops.

    Keep out of reach of children.

    If swallowed, get medial help or contact a doctor immediately.

  • Directions

    Place pea sized drop onto hands. Rub until absorbed. Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    Store between 15-30° C (59-86°F).

    Avoid freezing and excessive heat above 40°C (104°F).

  • Inactive Ingredients

    Alcohol(Denat), Aqua, Parfum, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Denatonium Benzoate, Aloe Barbadensis Leaf Juice, Maltodextrin, Limonene, Linalool.

  • Questions or Comments

    MAD BEAUTY USA LLC 1030 SALEM ROAD UNION NJ 07083 MARYLAND TEL (844) 995 1701

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    WARNER FRIENDS MOISTURIZING HAND SANITIZER APPLE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78789-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78789-026-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/202012/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/20/202012/31/2024
    Labeler - Mad Beauty USA LLC (117508758)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!