Label: RAREESSENCE HAND SANITIZER- ethyl alcohol liquid

  • NDC Code(s): 78035-001-01, 78035-001-02, 78035-001-03, 78035-001-04, view more
    78035-001-05, 78035-001-06
  • Packager: rareESSENCE, LLC
  • 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 June 2, 2020

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

  • ACTIVE INGREDIENT

    Ethyl Alcohol 70%

  • PURPOSE

    Hand & Skin Antiseptic

  • INDICATIONS & USAGE

    Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin

  • WARNINGS

    For external use only

    Flammable: Keep away from heat and flame

    * Keep out of eyes, ears, and mouth.

    * In case of contact with eyes, rinse eyes thoroughly with water.

    * If irritation or rash occurs and persists for more than 72 hours.

    * If irritation or rash occurs and persists for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    * Wet hands thoroughly with product and allow to dry without wiping.

    * Supervise children under 6 years of age.

  • INACTIVE INGREDIENT

    Purified water, Vegetable Glycerin, Organic orange oil, Organic French Lavender oil, Organic Lavandin oil, Organic Lemon Oil, Vitamin E

  • QUESTIONS

    Questions? 800.998.1762

  • PRINCIPAL DISPLAY PANEL

    rareESSENCE AROMATHERAPY

    Spray It Away (TM)

    Hand Sanitizer

    Alcohol Antiseptic 70%

    With Pure essential oils

    Lavender orange

    Feel good. Do good.

    For every bottle you purchase, we will donate a portion of the proceeds to U.S. food shelves.

    With 100% Pure Essential Oils

    No Synthetic Frangrances

    No Phthalates

    No Parabens

    Reduceds Germs that can potentially cause disease

    Washing hands with soap and warm water remains the best way to remove germs. For use when souap and water are not available.

    Made in USA

    rareEssence, LLC

    Minneapolis, MN 55344

    www.rareEssenccearomatherapy.com

    xx oz (zzzmL) NDC 78035-001-xx

    Spray It Away Hand Sanitizer 48x4oz

    Spray It Away Hand Sanitizer 48x2oz

    Spray It Away Hand Sanitizer 12x4oz

    Spray It Away Hand Sanitizer 12x2oz

    Spray It Away Hand Sanitizer 4oz

    Spray It Away Hand Sanitizer 2oz

  • INGREDIENTS AND APPEARANCE
    RAREESSENCE HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78035-001
    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
    WATER (UNII: 059QF0KO0R)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEMON OIL (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78035-001-0348 in 1 CARTON06/02/2020
    1NDC:78035-001-0212 in 1 CASE
    1NDC:78035-001-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:78035-001-0648 in 1 CARTON06/02/2020
    2NDC:78035-001-0512 in 1 CASE
    2NDC:78035-001-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - rareESSENCE, LLC (011585557)
    Registrant - rareESSENCE, LLC (011585557)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diversified Manufacturing Corporation185073996manufacture(78035-001) , pack(78035-001) , repack(78035-001) , label(78035-001)