Label: HAND SANITIZER 1.8 OZ WATERMELON SCENTED 1.8 OZ.- ethyl alcohol liquid

  • NDC Code(s): 57337-111-01
  • Packager: Ningbo Rejoice International
  • 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 April 3, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Ethyl Alcohol 70.0% v/v

  • PURPOSE

    Antimicrobial

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin that may cause disease

  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame

  • WHEN USING

    When using this product

    • avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice
  • STOP USE

    Stop use and ask a doctor

    • if irritation and redness develop
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product and rub into skin until dry.
    • Children under 6 years of age should be supervised by an adult when using
  • OTHER SAFETY INFORMATION

    Other Information

    • store at room temperature
    • may discolor certain fabrics
  • INACTIVE INGREDIENT

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate (Vitamin E), aloe barbadensis leaf extract, fd&c yellow no. 5, fd&c blue no. 1

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 1.8 OZ WATERMELON SCENTED  1.8 OZ.
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-111
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-111-0153 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/05/2020
    Labeler - Ningbo Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Technology Co., Ltd.529287434manufacture(57337-111)
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!