801 Large Alcohol Prep Pad

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., Lights Medical Manufacture Co., Ltd., Yinjing Medical Technology (Shanghai) Co., Ltd., Phoenix Innovative Healthcare Manufacturers Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDLINE ALCOHOL PREP NON-STERILE, LARGE- 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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801 Large Alcohol Prep Pad

Active ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Uses

• for first aid to help prevent infection in minor cuts, scrapes, burns
• for preparation of the skin prior to injection

Warnings

For external use only.

When using this product do not

• get into eyes
• apply over large areas of the body
• in case of deep puncture wounds, animal bites or serious burns, consult a doctor

Stop use and ask a doctor if

• condition persists or gets worse or lasts longer than 72 hours
• do not use longer than 1 week unless directed by a doctor

Flammable

• keep away from fire or flame
• do not use with electrocautery procedures
• use only in a well ventilated area; fumes may be toxic

Keep out of reach of children.

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

Directions

Apply to skin as needed. Discard after single use.

Other information

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Water

Package/Label Principal Display Panel

MEDLINE

NDC: 53329-801-30

Large

Alcohol Prep Pads

REF MDS090675

Directions: tear open packet, apply topically as needed to cleanse intended area. Discard appropriately after single use.

Avoid excessive heat, Store at room temperature. For external use only.

Latex Free

Contents: 100 Each

Package/Label Back

MEDLINE ALCOHOL PREP  NON-STERILE, LARGE
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-801
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: 53329-801-30	100 in 1 BOX	01/01/2007	01/01/2013
1	NDC: 53329-801-09	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	01/01/2007	01/01/2013

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Haiyan Medical Manufacture Co., Ltd.		421283439	manufacture(53329-801)

Establishment
Name	Address	ID/FEI	Business Operations
Lights Medical Manufacture Co., Ltd.		529128649	manufacture(53329-801)

Establishment
Name	Address	ID/FEI	Business Operations
Yinjing Medical Technology (Shanghai) Co., Ltd.		530501535	manufacture(53329-801)

Establishment
Name	Address	ID/FEI	Business Operations
Phoenix Innovative Healthcare Manufacturers Private Limited		650687176	manufacture(53329-801)

Revised: 12/2019

Document Id: 9a9dd700-d1b1-0da9-e053-2a95a90a490a

34390-5

Set id: e0294618-9560-41e9-a2ea-8b3a03532150

Version: 6

Effective Time: 20191226

 

Medline Industries, Inc.