ALCOHOL CLEANSING- isopropyl alcohol swab
GFA Production (Xiamen) 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.

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Alcohol Cleansing Pad

DRUG FACTS

Active Ingredient:

Isopropyl Alcohol, 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:

Label

ALCOHOL CLEANSING
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50814-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	700 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50814-001-01	1 in 1 BOX	03/22/2016	12/31/2019
1		0.45 g in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/22/2016	12/31/2019

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

Revised: 1/2021

Document Id: 995ac1db-16fe-3ab1-e053-2995a90a9469

Set id: a2d19e53-588b-47a6-a939-12c0c226aee4

Version: 4

Effective Time: 20210126

GFA Production (Xiamen) Co., Ltd.