RAINING ROSE ANTISEPTIC HAND SANITIZER  - 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.

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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

image of vial label
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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
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)

Revised: 11/2012
Document Id: 045aa4c0-de11-49ac-ade1-c590ed992d38
Set id: 18ae726c-a1ec-4cce-8424-766138f9052c
Version: 2
Effective Time: 20121130
 
Raining Rose, Inc.