Label: ANTISEPTIQUE 70- alcohol 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 29, 2020

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purposes

    Antiseptic

  • Uses

    to help reduce bacteria on skin

  • Warnings

    |For external use only | Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge

    Do not use

    |In eyes | On children less than 2 years of age | On open skin wounds

    When using this product

    |If in eyes, rinse promptly and thoroughly with water | Discontinue use if irritation and redness develops

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

    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

    | Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F) | For additional information, see Safety Data Sheets (SDS)

  • Inactive Ingredients

    water (aqua), propylene glycol, dimethicone PEG-7 Isostearate, acrylates/ C10-30 Alkyl Acrylate Crosspolymer, aminomethylpropanediol, tocopherol acetate, aloe barbadensis leaf juice

  • Questions?

    sales@tri-pac.us

  • PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label

    ANTISEPTIQUE+70
    gel sanitizer

    antiseptic | rinse-free | 70% alcohol

    FOR HANDS
    dye free, fragrance free

    FOR HEALTHCARE PROFESSIONALS ONLY

    32 FL. OZ. (946 ML)

    PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIQUE 70 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72138-460
    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
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DIMETHICONE PEG-8 ISOSTEARATE (UNII: JGV7463UFN)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Tocopherol (UNII: R0ZB2556P8)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72138-460-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    2NDC:72138-460-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    3NDC:72138-460-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/2020
    4NDC:72138-460-32946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/25/2020
    Labeler - Hubot Healthcare LLC (081084880)
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!