Label: HAND GEL 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 October 16, 2020

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

View All Sections
  • Active Ingredient(s)

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use

  • Warnings

  • Do not use

    Do not apply around eyes. Do not use in ears or mouth.

  • WHEN USING

    When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

    Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

    Keep out of reach of children. Children must be supervised in use of this product.

  • STOP USE

    Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • Directions

    Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

  • Other information

    Do not store in temperature over 118°F.

  • Inactive ingredients

    Water, Propylene Glycol, Glycerin, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine, Fragrance. May Contain: FD & C Red No. 4, FD & C Blue No. 1, FD & C Yellow No 5.

  • Package Label - Principal Display Panel

    70483-018-01 30ML70483-018-02 30ML70483-018-03 30ML

  • INGREDIENTS AND APPEARANCE
    HAND GEL 
    hand gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70483-018
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70483-018-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:70483-018-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:70483-018-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Jean Pierre Inc. (138328393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jean Pierre Inc.138328393label(70483-018)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou meizi biotechnology co. LTD403308233manufacture(70483-018)
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!