RAINING ROSE ANTISEPTIC HAND SANITIZER - ethyl alcohol spray
Raining Rose, Inc.

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.

----------

Active ingredient
Ethyl Alcohol 62%

Purpose
Antiseptic

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

Warnings
For external use only.

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.

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

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

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 Ingredients
Water, glycerin, propylene glycol,

aloe barbadenis leaf Juice, fragrance

RAINING ROSE ANTISEPTIC HAND SANITIZER
ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65692-1001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65692-1001-8	8 mL in 1 VIAL, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/30/2012

Labeler - Raining Rose, Inc. (083819404)