Label: ALCOHOL FREE 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

    Benzalkonium Chloride..........0.3%

  • PURPOSE

    Uses:
    Keep skin Clean. 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:

    Squeeze small amount in your palm and briskly rub hands together until dry.

  • 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,Cellulose,Triethanolamine,Ethoxylated hydrogenated castor oil,Glycerine,Fragrance

  • PRINCIPAL DISPLAY PANEL

    image of Alcohol Free Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE HAND SANITIZER 
    alcohol free hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 94.7 g  in 100 g
    ALPHA CELLULOSE (UNII: I355QGZ19A) 1.4 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 1 g  in 100 g
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.4 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    AROMADENDRIN (UNII: 7YA4640575) 0.2 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-231-0110 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    2NDC:47993-231-0215 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    3NDC:47993-231-0330 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    4NDC:47993-231-0450 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    5NDC:47993-231-0560 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    6NDC:47993-231-06100 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    7NDC:47993-231-07237 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    8NDC:47993-231-08500 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    9NDC:47993-231-09800 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/20/2015
    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(47993-231)
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