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Name:Alcohol Prep Pad
Manufacturer:Wuxi Medical Instrument Factory
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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# 83791-818-016      NDC# 42947-650-16      Qty. 1ea

Alcohol Prep Pad

Antiseptic * Sterile, 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

Pouch Label


ALCOHOL PREP PAD 
isopropyl alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42947-650
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER 0.3 mL  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42947-650-16 0.4 mL in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 01/01/2009

Labeler - Wuxi Medical Instrument Factory (421292863)
Registrant - Wuxi Medical Instrument Factory (421292863)
Establishment
Name Address ID/FEI Operations
Wuxi Medical Instrument Factory 421292863 manufacture

Revised: 03/2010 Wuxi Medical Instrument Factory



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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