COMFORT- alcohol liquid
WEIMEI Lianyungang Household Articles Manufacturing Co. LTD

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.

----------

Active Ingredient

Isopropyl Alcohol 50%

Purpose

First Aid Antiseptic

Uses

Help Prevent risk of infection in minor cuts, scrapes, burns

Warnings

For external use only

Flammable- keep away from fire or flame, heat, spark, electrical.

Ask a doctor before use if you have deep or punture wounds, animal bites or serious burns

Stop use and ask doctor if the condition persists or gets worse

When using this product, do not get into eyes, do not apply over large area of the body, do not use longer than 1 week

Keep out of reach of children

If swallowed, get medical help or contact a posion control center immediately

Directions

Clean affected area - apply a small amount of product 1 to 3 times a day

Other Information

does not container nor is intended as substitue for grain or ethyl alcohol, will produce serious gastric disturbances if taken internally

Inactive Ingredient

Water, Blue 1, yellow 5

Label

Winter Green Alcohol

COMFORT
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50827-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	50 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50827-003-80	354 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2013

Labeler - WEIMEI Lianyungang Household Articles Manufacturing Co. LTD (546100731)

Registrant - WEIMEI Lianyungang Household Articles Manufacturing Co. LTD (546100731)

Name	Address	ID/FEI	Business Operations
Establishment
Weimei Lianyungang Household Manufacturing Co. LTD		546100731	manufacture(50827-003)