Label: RAINING ROSE ANTISEPTIC HAND SANITIZER  - alcohol spray 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • ACTIVE INGREDIENT

    Active ingredient
    Ethyl Alcohol 62%
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  • PURPOSE

    Purpose
    Antiseptic
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  • INDICATIONS & USAGE

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

    Warnings
    For external use only. Close
  • 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. Close
  • STOP USE

    Discontinue Use
    if irritation and redness develops. If condition persists for more than 72 hours consult a doctor. Close
  • 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. Close
  • 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. Close
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water, glycerin, propylene glycol, 

    aloe barbadenis leaf Juice, fragrance

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  • INGREDIENTS AND APPEARANCE
    RAINING ROSE ANTISEPTIC HAND SANITIZER  
    ethyl alcohol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65692-1001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Alcohol (Alcohol) Alcohol 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    PROPYLENE GLYCOL  
    ALOE VERA LEAF  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65692-1001-8 8 mL in 1 VIAL, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 11/30/2012
    Labeler - Raining Rose, Inc. (083819404)
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