ALCOHOL PREP PAD - isopropyl alcohol swab 
Wuxi Medical Instrument Factory

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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Drug Facts

Item# 83791-818-010      NDC# 42947-650-10      Qty. 1ea

Alcohol Prep Pad

Antiseptic * Medium, 2-ply * Saturated with 70% isopropyl alcohol

Sterile if unopened, undamaged

For External Use Only

Manufactured by:

Wuxi Medical Instrument Factory

No.86 East Street, Zhangjing, Wuxi, Jiangsu 214194 China

Made in China


Active Ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use

For preparation of 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

if irritation or redness develop.

if the condition persists for more than 71 hours, consult a doctor.


Keep out of reach of children.

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

Directions

Wipe injection site vigorously and discard

Inactive ingredient

purified water




Image of Pouch Label

Alcohol Prep Pad

ALCOHOL PREP PAD 
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42947-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.3 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42947-650-100.4 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33301/01/2009
Labeler - Wuxi Medical Instrument Factory (421292863)
Registrant - Wuxi Medical Instrument Factory (421292863)
Establishment
NameAddressID/FEIBusiness Operations
Wuxi Medical Instrument Factory421292863manufacture

Revised: 3/2010
Document Id: adb315dd-9271-4fbe-baa3-6c6148cebadf
Set id: 939eab0f-e59c-449d-9d44-668bbeb60456
Version: 3
Effective Time: 20100301
 
Wuxi Medical Instrument Factory