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 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

Package Label Back
MEDLINE ALCOHOL PREP  MEDIUM
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-809
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-809-30100 in 1 BOX12/07/201201/01/2013
1NDC: 53329-809-091 in 1 PACKET
15 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/07/201201/01/2013
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Haiyan Medical Manufacture Co., Ltd421283439manufacture(53329-809)
Establishment
NameAddressID/FEIBusiness Operations
Phoenix Innovative Healthcare Manufacturers Private Limited650687176manufacture(53329-809)

Revised: 12/2019
 
Medline Industries, Inc.