Label: RAINING ROSE ANTISEPTIC HAND SANITIZER- ethyl alcohol spray

  • Category: HUMAN OTC DRUG LABEL

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 November 30, 2012

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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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