Label: SAFE AND CLEAN- 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 August 7, 2020

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

View All Sections
  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    May discolor certain fabrics or surfaces

  • Inactive ingredients

    aloe vera extract, glycerin, hydrogen peroxide, carbomer, methylchloroisothiazolinone, trolamine, water, denatonium benzoate

  • Package Label - Principal Display Panel

    250ML NDC: 79990-111-12

    250 mL NDC: 79990-111-12

  • INGREDIENTS AND APPEARANCE
    SAFE AND CLEAN 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79990-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79990-111-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
    2NDC:79990-111-12250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
    3NDC:79990-111-13500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
    4NDC:79990-111-141000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
    5NDC:79990-111-155000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/07/2020
    Labeler - SNC Industria de Cosmeticos Ltda (914610642)
    Establishment
    NameAddressID/FEIBusiness Operations
    SNC Industria de Cosmeticos Ltda914610642manufacture(79990-111)
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!