Label: RN WELLNESS SANITIZER- ethyl alcohol liquid

  • 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 July 10, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Ethanol 70%

  • Purpose:

    Antiseptic

  • Uses:

    -For hand washing to decrease bacteria on skin.

    -Recommended for repeated use

  • WARNINGS:

    -Flammable, keep away from fire or flame.

    -For external use only.

    -Do not use in eyes. If contact occurs, flush thoroughly with water

    -Stop use and ask a doctor if redness and irritation develop and persist for more than 72 hours.

    -Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

  • -Directions:

    Wet hands thoroughly with product and allow to dry without wiping

    -Do not use other than directed

  • STORAGE AND HANDLING

    Store at room temperature 20-25 °C (66-77 °F)

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aqua, Glycerin, Tocopherol.

  • 59.15 mL NDC: 79556-123-02

    RN Wellness Hand Sanitizer Label

  • INGREDIENTS AND APPEARANCE
    RN WELLNESS SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79556-123(NDC:74306-133)
    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
    THYME OIL (UNII: 2UK410MY6B)  
    WATER (UNII: 059QF0KO0R)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79556-123-0259.15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/10/2020
    Labeler - RN Wellness (802028444)
    Registrant - RN Wellness (802028444)
    Establishment
    NameAddressID/FEIBusiness Operations
    RN Wellness802028444relabel(79556-123)