Medline Alcohol Prep by Medline Industries, Inc. / Shandong Haiyan Medical Manufacture Co., Ltd / Phoenix Innovative Healthcare Manufacturers Private Limited 809 Medline Prep Pads

Medline Alcohol Prep by

Drug Labeling and Warnings

Medline Alcohol Prep by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc., Shandong Haiyan Medical Manufacture Co., Ltd, Phoenix Innovative Healthcare Manufacturers Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDLINE ALCOHOL PREP MEDIUM- isopropyl alcohol swab 
Medline Industries, Inc.

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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809 Medline Prep Pads

Active ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use

• for preparation of the skin prior to injection

Warnings

For external use only. Flammable, keep away from fire or flame

Do not use

• with electrocautery procedures
• in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• if condition gets worse or persists for more than 72 hours

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

Protect from freezing, avoid

excessive heat.

Inactive ingredients

Water

Package Label - Principal Display Panel

Medline

Prep Pads

Sterile

REF MDS090731

Alcohol Antiseptic

LATEX FREE

Saturated with

70% Isopropyl Alcohol

2-Ply Pad

Individually Wrapped

Qty 100

Package Label - Back

MEDLINE ALCOHOL PREP  MEDIUM
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-809
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 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-809-30	100 in 1 BOX	12/07/2012	01/01/2013
1	NDC: 53329-809-09	1 in 1 PACKET
1		5 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/07/2012	01/01/2013

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Haiyan Medical Manufacture Co., Ltd		421283439	manufacture(53329-809)

Establishment
Name	Address	ID/FEI	Business Operations
Phoenix Innovative Healthcare Manufacturers Private Limited		650687176	manufacture(53329-809)

Revised: 12/2019

Document Id: 9a9deba5-6e56-4fc2-e053-2995a90a3727

34390-5

Set id: f6f2228e-1294-45f4-942f-8ddf111e2d4e

Version: 6

Effective Time: 20191226

 

Medline Industries, Inc.