SANELL HAND SANITIZER (ALCOHOL) GEL [ORALABS]

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SANELL HAND SANITIZER (ALCOHOL) GEL [ORALABS]
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NDC 63645-166-01
Set ID e3b85008-4455-46d1-ad33-fb0c69aeb60c
Category HUMAN OTC DRUG LABEL
Packager OraLabs
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active ingredient

    Ethyl Alcohol 63.00%

  • Purpose

    Antiseptic

  • Keep Out of Reach of Children

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

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only: Hands. Flammable. Keep away from fire or flame. When using this product: keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor: if irritation and redness develop. Condition persists for more than 72 hours.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • Inactive Ingredients

    Carbomer, DMDM Hydantoin, Fragrance, Isopropanol, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

  • Package/Label Principal Display Panel

    Front Label - Sanell Hand Sanitizer
  • INGREDIENTS AND APPEARANCE
    SANELL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-166
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL58.10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.010 mg  in 1 g
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) .310 mg  in 1 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .500 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63645-166-011 g in 1 CONTAINER; Type 0: Not a Combination Product03/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/07/2018
    Labeler - OraLabs (801824756)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(63645-166) , LABEL(63645-166)
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