Label: SANELL HAND SANITIZER- alcohol spray

  • 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 April 16, 2021

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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. Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.. Stop use and ask a doctor: if irritation and redness develop and persists for more than 72 hours.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping. Supervise children in the use of this product.

  • Inactive Ingredients

    Dimethicone, Disodium EDTA, DMDM Hydantoin, Fragrance, Polysorbate 20, Propanediol, Water.

  • Package/Label Principal Display Panel

    Sanell Hand Sanitizer
  • INGREDIENTS AND APPEARANCE
    SANELL HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL4.275 mL  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) 0.003 mL  in 7.5 mL
    WATER (UNII: 059QF0KO0R) 2.6857 mL  in 7.5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63645-177-017.5 mL in 1 BOTTLE; 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(63645-177) , LABEL(63645-177)
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