Label: SWEET PEA SCENTED ANTIMICROBIAL HAND GEL- ethyl alcohol liquid

  • 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 March 22, 2018

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl Alcohol, 65% v/v

  • PURPOSE

    Purpose Antimicrobial

  • INDICATIONS & USAGE

    Uses hand sanitizer to help

    reduce bacteria on skin

  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away from

    fire or flame.

    Do not use in or near the eyes

    In case of contact, rinse eyes

    thoroughly with water.

    Stop use and ask a doctor if

    irritation, excessive redness

    or rash develops.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions  Put a dime sized

    drop onto hands and rub

    together briskly until dry.

  • STORAGE AND HANDLING

    Other information

    Store below 110° F (43° C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, glycerin, propylene

    glycol, fragrance, carbomer,

    triethanolamine, blue 1,

    red 33

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SWEET PEA SCENTED ANTIMICROBIAL HAND GEL 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-824
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 g  in 100 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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43473-824-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/22/2018
    Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(43473-824)
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!