REFILL 4- isopropyl alcohol cloth

Refill 4 by

Drug Labeling and Warnings

Refill 4 by is a Otc medication manufactured, distributed, or labeled by GFA Production (Xiamen) Co., Ltd., Lights Medical Manufacture Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS : Alcohol Cleansing Pad

Active Ingredient:

Isopropyl Alchol 70% v/v

Purpose:

Antiseptic

Use:

For preparation of the skin before injection.

Warnings

For external use only.

Flammable - keep away from fire or flame.

Do not use:

with electrocautery, in the eyes 

Stop use

if irritation and redness develop, If condition persists for more than 72 hours, consult your doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Wipe injection site vigorously and discard.

Other information:

Store at room temperature 15°-30° C 59°-86° F)

Inactive ingredient:

Purified water.

Package Labeling:

INGREDIENTS AND APPEARANCE

REFILL 4 
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50814-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-018-01	20 in 1 BOX	08/06/2016
1		0.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	08/06/2016

Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)

Establishment
Name	Address	ID/FEI	Business Operations
Lights Medical Manufacture Co., Ltd.		529128649	manufacture(50814-018)