Label: DERMACEN INSTANT HAND SANITIZER- alcohol liquid

  • NDC Code(s): 62654-140-02, 62654-140-03, 62654-140-36, 62654-140-90, view more
    62654-140-91, 62654-140-92, 62654-140-93
  • Packager: Central Solutions Inc
  • 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 5, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients

    Ethanol 64.5% (w/w)

  • PURPOSE

    Purpose

    Hand Sanitizer

  • INDICATIONS & USAGE

    Uses

    An antiseptic hand sanitizer for topical application

    Prevents infection and cross contamination

    Reduces transient microorganisms on intact skin

    Keep hands from drying due to repeated uses

  • WARNINGS

    Warnings

    For External Use Only

    Flammable, keep away from fire or flame

    When using this product

    Avoid contact with eyes

    In case of eye contact, flush with water for 15 minutes

    Discontinue use and see a doctor if irritation occurs

    Avoid contact with broken skin

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands thoroughly with product.

    Allow to dry without wiping.

    Use no water or towels.

  • USER SAFETY WARNINGS

    Other Information

    This product has not been tested on animals.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Tetrahydroxypropyl Ethylenediamine, Water

  • PRINCIPAL DISPLAY PANEL

    DermaCen

    Instant

    Hand Sanitizer

    For hand washing to decrease bacteria on the skin.

    Net Contents 8 ounces (236 ml)

    container label

  • INGREDIENTS AND APPEARANCE
    DERMACEN INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol64.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-140-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
    2NDC:62654-140-03443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
    3NDC:62654-140-36800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
    4NDC:62654-140-901000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
    5NDC:62654-140-921250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
    6NDC:62654-140-911000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/05/2018
    7NDC:62654-140-932000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2001
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-140)
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