ALCOHOL PREP PAD- alcohol swab
Zhejiang Changdi Medical 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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Active Ingredient

Isopropyl Alcohol 70%

Purpose

Antiseptic

Use

For preparation of skin prior to an injection

Warnning

For External use only.

Flammabel,keep away from fire or flame

Do not use

with electrocautery procedures,
in the eyes,

stop use if irritation and redness develop.

Ask a doceor if condition persists for more than 72 hours

Keep out of reach of children except with adult supervision.

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

Directions

wipe injection site vigorously and discard

Other informaiton store at room temperature

Inactive Ingredients

Inactive Ingredients: Water

label

ALCOHOL PREP PAD
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59194-002
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	70 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water	30 mL in 100 mL

Packaging
#	Item Code	Package Description
1	NDC:59194-002-01	24 in 1 CARTON
1		100 in 1 BOX
1		0.49 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/02/2013

Labeler - Zhejiang Changdi Medical Co., Ltd. (528198683)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Changdi Medical Co., Ltd.		528198683	manufacture(59194-002)

Revised: 07/2013

Document Id: ede7a390-e8a7-402a-8a8a-9c7d06ce6f5e

Set id: f7cdca16-cb32-4734-a9c7-25dd9a7ee2fc

Version: 1

Effective Time: 20130703

Zhejiang Changdi Medical Co., Ltd.