ANTI BACTERIAL HAND SANITIZER - ethyl alcohol liquid
Tri-Coastal Design Company 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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Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin

Warnings

For external use only
Flammable, keep away from fire and flame

Does not contain grain alcohol. Do not drink. If taken internally will produce serious gastric disturbances

Avoid the eyes and mucous membranes.
In case of contact; rinse area thoroughly with water

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

Rub dime sized amount between hands until dry

Other Information

Store below 105F
May discolor some fabrics

Inactive Ingredients

Benzophenone-4, Carbomer, Fragrance, FDC Red 40, DC Red 33, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol and Jojoba Oil, Triethanolamine, Water (Aqua)

Package Label

ANTI BACTERIAL HAND SANITIZER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49852-069
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
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)
JOJOBA OIL (UNII: 724GKU717M)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:49852-069-30	30 mL in 1 BOTTLE, PLASTIC
2	NDC:49852-069-40	40 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/15/2011

Labeler - Tri-Coastal Design Company Inc. (609734900)