WATERLESS ANTI-BACTERIAL HAND CLEANSER - 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
Recommended for repeated use

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

When using this product

avoid the eyes an mucous membranes
in the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop use and ask a doctor if

condition worsens
redness or irritation develops
if condition persists for more than 3 days

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

rub quarter sized amount between hands until dry
supervise children in the use of this product
in the case of eye contact, rinse eyes thoroughly with water

Other information

store below 105F
may discolor some fabrics

Inactive Ingredients

Benzophenone-4, Carbomer, DC Orange 4, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol, Jojoba Oil, Triethanolamine, Water

Package Label

WATERLESS ANTI-BACTERIAL HAND CLEANSER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49852-015
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
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:49852-015-08	250 mL in 1 BOTTLE, PLASTIC
2	NDC:49852-015-60	60 mL in 1 BOTTLE, PLASTIC
3	NDC:49852-015-45	45 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	12/01/2009

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

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou St Eva Fine Chemical Co Ltd		528039793	manufacture