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 and mucous membranes
In the case of eyes or mucous membrane contact; rinse area thoroughly with water Use only as directed

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 (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Jojoba Esters, Red 4, Red 33

Package Label

image description

ANTI-BACTERIAL HAND CLEANSER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49852-301
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 (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49852-301-30	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014
2	NDC:49852-301-45	45 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/01/2014

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

Name	Address	ID/FEI	Business Operations
Establishment
Ganzhou Olivee Cosmetic Co., Ltd.		543008195	manufacture(49852-301)