Label: ANTIBACTERIAL HAND SANITIZER- alcohol solution

  • NDC Code(s): 82953-008-01, 82953-008-02, 82953-008-03, 82953-008-04, view more
    82953-008-05
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd
  • 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 August 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Fact

  • Active Ingredient(s)

    Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    To decrease the bacteria on the skin that could cause disease

    Recommended for repeated use

  • Warnings

    For external use only-Hands

    Flammable. Keep away from heat and flame

    Stop use and ask a doctor if skin irritation develops

  • WHEN USING

    When use this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.  Do not inhale or ingest

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Wet hands thoroughly with products and allow to dry without wiping

    For children under 6, use only under adult supervision

    Not recommended for infants

  • Other information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wooden finishes and plastics

  • Inactive ingredients

    Water, glycerin, propylene glycol, aloe barbadensis leaf extract, carbomer, triethanolamine, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE (UNII: V5VD430YW9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-008-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
    2NDC:82953-008-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
    3NDC:82953-008-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
    4NDC:82953-008-0474 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
    5NDC:82953-008-050.9 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/29/2020
    Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd (725290934)
    Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd (725290934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmuses Cosmetics (Ningbo) Co., Ltd725290934manufacture(82953-008)
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