RAINING ROSE ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) SPRAY [RAINING ROSE, INC.]

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RAINING ROSE ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) SPRAY [RAINING ROSE, INC.]
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NDC 65692-1001-8
Set ID 18ae726c-a1ec-4cce-8424-766138f9052c
Category HUMAN OTC DRUG LABEL
Packager Raining Rose, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active ingredient
    Ethyl Alcohol 62%
  • PURPOSE

    Purpose
    Antiseptic
  • INDICATIONS & USAGE

    Uses
    For hand washing to decrease bacteria on the skin
    Recommended for repeated use
    Flammable. Keep away from heat and flame.
  • WARNINGS

    Warnings
    For external use only.
  • WHEN USING

    When using this product
    Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin.
  • STOP USE

    Discontinue Use
    if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    Wet hands thoroughly with product and allow to dry without wiping
    Children under 6 of age should be supervised when using this product.
    Not recommended for infants.
    Other Information
    Do not store above 105 degrees F.
    May discolor some fabrics.
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water, glycerin, propylene glycol, 

    aloe barbadenis leaf Juice, fragrance

  • PRINCIPAL DISPLAY PANEL

    image of vial label
  • INGREDIENTS AND APPEARANCE
    RAINING ROSE ANTISEPTIC HAND SANITIZER  
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-1001-88 mL in 1 VIAL, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/30/2012
    Labeler - Raining Rose, Inc. (083819404)
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