Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 7, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Hand Sanitizer to help reduce bactreia on skin.

  • Use

    Hand Sanitizer to help reduce bacteria on skin.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

  • Do not use

    Do not use in or near the eyes.

    In case of contact, rinse eyes thoroughly with water.

  • WHEN USING

    When using this product, do not use in or near the eyes.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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.

  • Directions

    • Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 106℉ (41℃)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water (Aqua), Olive Oil PEG-7 Esters, Acrylates/C10-30 Alkyl, Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract

  • Package Label - Principal Display Panel

    N 236

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74738-1105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL165.2 mL  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-7 STEARATE (UNII: VCX261B12R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74738-1105-724 in 1 CARTON05/07/2020
    1NDC:74738-1105-2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/07/2020
    Labeler - GuangDong B.C. Biotech Co., Ltd. (403932907)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    GuangDong B.C. Biotech Co., Ltd.403932907manufacture(74738-1105) , label(74738-1105)
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

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!