Label: HAND SANITIZER gel

  • 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 November 4, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients

    Ethyl Alcohol 62%

  • PURPOSE

    Antiseptic

  • WARNINGS

    Warnings:

    For external use only. Flammable. Keep away from fire or flame.

  • DO NOT USE

    Do not apply around eyes. Do not use in ears & mouth.

  • WHEN USING

    When using this product,avoid contact with eyes. In case of contact flush eyes with water.

  • ASK DOCTOR

    Stop use and as a doctor if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children,Children must be supervised in use of this product.

  • INDICATIONS & USAGE

    Uses:

    Hand sanitizer to help decrease bacteria on the skin.
    When water, soap & towel are not available.
    Recommended for repeated use.

  • DOSAGE & ADMINISTRATION

    Directions:

    Pump as needed into your palms and thoroughly spread on both hands.
    Rub into skin until dry.

  • OTHER SAFETY INFORMATION

    Store at 20 ℃(68 to77℉)
    May discolor fabrics.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water,Carbomer 940,Triethanolamine,Glycerin,Aloe barbadensis leaf juice,Fragrance,CI16185,CI42090

  • PRINCIPAL DISPLAY PANEL

    237ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-233
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 112 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER 940 (UNII: 4Q93RCW27E) 12 g  in 112 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 g  in 112 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 112 mL
    WATER (UNII: 059QF0KO0R)  
    AMARANTH (UNII: 37RBV3X49K)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) 3 g  in 112 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-233-01237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)