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

Alcohol 62%

Purpose

Antiseptic

Use

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 and 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 dime 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

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, PEG-40 Hydrogenated Castor Oil, Jojoba Esters

Questions?

1-800-278-9218

Package Label

package label

ANTI BACTERIAL HAND SANITIZER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49852-304
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49852-304-30	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/09/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/09/2016

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