Label: 75% ALCOHOL 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 June 27, 2020

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

View All Sections
  • Active Ingredient(s)

    Alcohol 75% v/v.

  • Purpose

    Antiseptic

  • Use

    Helps reduce bacea at pontentially can caus dsease

    Helps prevent Cross contamination on contact

    Recommended for repeated use

  • Warnings

    For external use only

    Flammable, Keep away from fire or flame

    Do not use near eyesIn case of eye contact flush with water for 15 minutes

    If imitation persists stop use of product and get medical attention

    Keep out of reach of childrenIn case of accidental ingestion seek medical attention orcontact a poison contro center immediately

  • Do not use

    • Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water for 15 minutes
  • WHEN USING

    When using this product

    Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water

  • STOP USE

    /

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. case of accidental ingestion seek medical attention orcontact a poison contro center immediately

  • Directions

    Wet hands thoroughly with product and rub completely Covering hands
    Allow to dry without wiping
    children under the age of 6 should use with adult supervision
    Not recommended for infants

  • Other information

    /

  • Inactive ingredients

    Water(Aqua), PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
    Fragrance (Parfum) Aminomethyl Propanol

  • Package Label - Principal Display Panel

    321

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL HAND SANITIZER 
    75% alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79316-008
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79316-008-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:79316-008-01250 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 - PHOENYX DISTRIBUTING, LLC (128029831)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHOENYX DISTRIBUTING, LLC128029831label(79316-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fortress Expert Co., Ltd543358697manufacture(79316-008)
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!