Label: HAND SANITIZER liquid

  • 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 December 6, 2017

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  • ACTIVE INGREDIENT

    Active ingredients--------------purpose

    Citric Acid，Sodium Laureth Sulfate，Coco Diethanolamide，Cocomidopropyl Betaine

  • PURPOSE

    Uses:
    Reduces bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    Warnings:

    For external use only.Keep out of eyes.In case of eye contact immediately flush with water,call a doctor.If swallowed call a doctor.

  • INDICATIONS & USAGE

    Directions:

    Rotate pump anti-clock wise to release the pump and press.

  • DOSAGE & ADMINISTRATION

    Other Information

    Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.


  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 years of age should be super vised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water,Fragrance,Sodium Chloride,Kathon,Disodium Edta

  • PRINCIPAL DISPLAY PANEL

    image of hand sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.3 g  in 100 g
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) (COCAMIDOPROPYL BETAINE - UNII:5OCF3O11KX) COCAMIDOPROPYL BETAINE5   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 15 g  in 100 g
    COCO DIETHANOLAMIDE (UNII: 92005F972D) 6 g  in 100 g
    EDETIC ACID (UNII: 9G34HU7RV0) 1 g  in 100 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 2 g  in 100 g
    AROMADENDRIN (UNII: 7YA4640575) 0.2 g  in 100 g
    ISOTHIAZOLINONE (UNII: E57JT172V7) 0.3 g  in 100 g
    WATER (UNII: 059QF0KO0R) 70.2   in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-204-01250 g in 1 BOTTLE; Type 0: Not a Combination Product09/26/2016
    2NDC:47993-204-02300 g in 1 BOTTLE; Type 0: Not a Combination Product09/26/2016
    3NDC:47993-204-03500 g in 1 BOTTLE; Type 0: Not a Combination Product09/26/2016
    4NDC:47993-204-041000 g in 1 BOTTLE; Type 0: Not a Combination Product09/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/26/2016
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD544493972manufacture(47993-204)
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