Label: DERMACEN FOAMING INSTANT HAND SANITIZER WITH ALOE- alcohol solution

  • NDC Code(s): 62654-149-13, 62654-149-14
  • 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 January 17, 2022

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  • Active Ingredient

    Ethanol 70%

  • Purpose

    Antiseptic

  • Uses

    • An effective antimicrobial hand cleanser for topical application
    • Recommended for repeated use
    • Reduces transient microorganisms on intact skin
    • Keeps hands from drying out due to repeated uses
  • Warnings

    • For External Use Only
    • Flammable, keep away from fire or open 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.

  • Directions

    Wet hands thoroughly with product. Allow to dry without wiping. Use no water or towels

  • Other information

    Not tested on animals

  • Inactive Ingredients

    Purified Water, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Compolymer/Perfluorohexyethyl Alcohol, Glycereth 26, Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice

  • Questions?

    Call 800-255-0262

  • PRINCIPAL DISPLAY PANEL

    DermaCen

    Foaming

    Instant Hand

    Sanitizer

    with Aloe

    For hand washing

    to decrease bacteria

    on the skin

    Net Contents

    8.5 oz (251 mL)

    container label

  • INGREDIENTS AND APPEARANCE
    DERMACEN FOAMING INSTANT HAND SANITIZER WITH ALOE 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-149-14251 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    2NDC:62654-149-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2015
    Labeler - Central Solutions Inc (007118524)
    Registrant - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-149)
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