ANTI-BACTERIAL HAND CLEANSER- ethyl alcohol liquid

anti-bacterial Hand Cleanser by

Drug Labeling and Warnings

anti-bacterial Hand Cleanser by is a Otc medication manufactured, distributed, or labeled by Tri-Coastal Design Company Inc., Ganzhou Olivee Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANTI-BACTERIAL HAND CLEANSER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49852-301
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2014

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

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