HAND SANITIZER- ethyl alcohol gel
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 Ingredients
Alcohol 62%

Purpose
Antiseptic

Warnings

Flammable, keep away from open flame and sources of heat. For external use only. Do not ingest.

Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention.

Stop use and ask doctor if irritation and redness develops and persists for more than 72 hours. Do not use if you are allergic to any ingredients.

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

Directions

Use 1.5mL and rub thoroughly into hands for at least 30 seconds. Allow to dry.
Does not require rinsing.

Inactive Ingredients: Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Vanilla Fragrance, Water.

Use

Kills some harmful bacteria/germs.
For occasional use, as needed.

Other Information

Do not store above 105 F
May discolor some fabrics.

image of bottle label

HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65692-1003
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65692-1003-1	17 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/15/2016

Labeler - Raining Rose, Inc. (083819404)