Label: 62% UNSCENTED- hand sanitizer 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 May 11, 2020

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

View All Sections
  • Active ingredients

    Ethyl Alcohol 62% v/v

    Purpose

    Antimicrobial

  • Uses

    Hand Sanitizer to help reduce bacteria on the skin

  • Warnings

    For external use only

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation develops.

    Flammability Warning: keep away from open flame and heat sources.

    Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

  • Directions

    For occasional and personal domestic use.

    Use enough to rub thoroughly into hands for at least 30 seconds. Allow to dry

    Supervise children when they use this product.

  • Inactive Ingredients

    Water, Glycerin, Hydroxypropyl Guar, Citric Acid, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice.

  • Other Information

    Store at temperature below 110 F (43 C)

  • Bottle label

    bottle label

  • INGREDIENTS AND APPEARANCE
    62% UNSCENTED 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76150-246-473785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/11/2020
    Labeler - Bell International Laboratories, Inc. (967781555)
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!