Label: HEMIRUS HAND CLINIC GEL 62%- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 March 31, 2020

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  • Active ingredients

    Alcohol 62%

    Antiseptic

  • Uses

    • hand sanitizer to help decrease bacteria on the skin.
    • when water, soap & tower are not available
    • recommended for repeated use
  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

    Do not apply around eyes. Do not use

    in ears & mouth

    When using this product

    avoid contact with eyes.

    In case of contact flush eyes with water

    Stop use and ask a doctor if

    redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    • pump as needed into your palms and throughly spread on both hands.
    • rub into skin until dry.
  • Other Information

    • Store at 20 o C (68 o to 77 o F).
    • may discolor fabrics.
  • Inactive Ingredients

    Water, Phenoxyethanol, Trolamine, Carbomer homopolymer type C (Allyl pentaerythritol crosslinked)
    Methylparaben, Orange, Isopropyl myristate, D&C Orange No. 4, Denatonium benzoate

  • Questions?

    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • ACCESSORIES

    Instant Hand Sanitizer!

    Kills 99.9% of Most Common Germs!

    Net Wt. 16.91 fl oz. (500ml)

    Manufactured by Woosincosmetics Inc.

    33, Sudo-ro, 125beon-gil, Bucheon-si,
    Gyeonggi-do, Korea 14491

  • PRINCIPAL DISPLAY PANEL

    500mL NDC: 71454-3040-1

    500 ml label

    100mL NDC: 71454-3040-2

    100 ml label

    30mL NDC: 71454-3040-3

    30 ml label

  • INGREDIENTS AND APPEARANCE
    HEMIRUS HAND CLINIC GEL 62% 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71454-3040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ORANGE (UNII: 5EVU04N5QU)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71454-3040-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2020
    2NDC:71454-3040-2100 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2020
    3NDC:71454-3040-330 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/31/2020
    Labeler - GC US CORPORATION (080669481)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOOSIN COSMETICS CO.,LTD688227829manufacture(71454-3040)
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