Label: FOAM HAND SANITIZER liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 19, 2020

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  • ACTIVE INGREDIENTS

    Sodium chloride 1.5%

  • Purpose

    Antiseptic

  • Uses

    Apply proper amount to palm, massage gently until foamy, then rinse with water.

  • Warnings

    This product is for external use only.

    When using this product In case of contact with eyes, rinse immediately with plenty of water.

    Stop using and ask a doctor if irritation or rash occurs. These may be signs of a serious condition
    Flammable. Keep away from heat or flame

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

  • DO NOT USE

    /

  • WHEN USING

    When using this product In case of contact with eyes, rinse immediately with plenty of water.

    Stop using and ask a doctor if irritation or rash occurs. These may be signs of a serious condition
    Flammable. Keep away from heat or flame

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

  • STOP USE

    Stop using and ask a doctor if irritation or rash occurs. These may be signs of a serious condition
    Flammable. Keep away from heat or flame

  • 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

    Scope of application: Household and personal cleaning.
    Main Effect Effective inhibition of microorganisms category intestinal bacteria, pyogenic coccus.

  • Other information

    Keep tightly closed. Store between 32°F and 109°F

  • Inactive ingredients

    Citric acid, Cocoamidopropyl betaine, Coconut oil amide DEA, Disodium EDTA, DMDM hydantoin, Essence, Sodium lauryl alcohol polyether sulfate, Water

  • Package Label - Principal Display Panel

    75132-012-01 3785ml75132-012-02 950ml75132-012-03 950ml BAG

  • INGREDIENTS AND APPEARANCE
    FOAM HAND SANITIZER 
    foam hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75132-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYL BENZOATE (UNII: 6618K1VJ9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75132-012-03950 mL in 1 BAG; Type 0: Not a Combination Product04/12/2020
    2NDC:75132-012-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
    3NDC:75132-012-02950 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/12/2020
    Labeler - Guangdong Kemei Pharmaceutical Technology Co., Ltd. (554528507)
    Registrant - Guangdong Kemei Pharmaceutical Technology Co., Ltd. (554528507)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Kemei Pharmaceutical Technology Co., Ltd.554528507manufacture(75132-012)
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