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 October 29, 2020

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  • ACTIVE INGREDIENT

    Active ingredients

    Ethyl Alcohol 62.5%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Uses:
    Helps reduce bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    Warnings:

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

  • WHEN USING

    When using this product. Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

  • STOP USE

    Stop use and ask doctor if irritation or redness develops, or if condition persists for more than 72 hours.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Squeeze small amount into the palms or your hands and massage gently. Allow to dry without wiping or rinsing.

  • OTHER SAFETY INFORMATION

    Other Information

    Store below 110F(Degrees Fahrenheit). May cause discoloration to certain fabrics and surfaces.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water，Carbomer 940，Triethanolamine，Glycerin，Aloe Barbadensis leaf juice

  • PRINCIPAL DISPLAY PANEL

    236ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 g  in 112 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) 3 g  in 112 mL
    WATER (UNII: 059QF0KO0R) 19.5 g  in 112 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 12 g  in 112 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 112 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 g  in 112 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-213-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/24/2020
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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