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Name:Alcohol Wipe
Manufacturer:Dorel Juvenile Group
Category:Over-the-counter (OTC) Marketed Drugs


1st™ Alcohol Wipe 70% Isopropyl Alcohol

ALCOHOL WIPE - isopropyl alcohol swab 
Dorel Juvenile Group

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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1st™ Alcohol Wipe 70% Isopropyl Alcohol

Active ingredients

Isopropyl Alcohol 70%

Purpose

Topical Antimicrobial use

Use

To clean infected area

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 72 hours, consult a doctor.

Keep out of reach of children.

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

Directions

Clean the infected area and discard.

Other information

Store at room temperature 15°C - 30°C (59°F - 86°F)

Inactive ingredients

purified water

Package/Label Principal Display Panel

1st™ Alcohol Wipe

70% Isopropyl Alcohol

EXTERNAL USE ONLY

For Home Use only

© 2010 Dorel Juv. Grp., Columbus, IN
1-877-657-9545
Made in CHINA
Model No. AL-01

Principal Display Panel - Package Label

Package Label


ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50428-0030
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL .70 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50428-0030-5 1 SWAB ( SWAB) in 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 07/20/2010

Labeler - Dorel Juvenile Group (118841501)
Establishment
Name Address ID/FEI Operations
Shanghai Yinjin Medical Supplies Co. Ltd 530501535 MANUFACTURE

Revised: 07/2010 Dorel Juvenile Group



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


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