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 prep skin prior to antimicrobial use.

Warnings

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 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

© 2012 Dorel Juv. Grp., Columbus, IN
1-877-657-9545 Made in CHINA
Model No. AL-01 NDC# 50428-0030

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 (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL .70 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50428-0030-5 1 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/20/2010
Labeler - Dorel Juvenile Group (118841501)
Establishment
Name Address ID/FEI Business Operations
Shanghai Yinjin Medical Supplies Co. Ltd 530501535 MANUFACTURE(50428-0030)

Revised: 10/2013
Document Id: 285f23e4-84e6-4930-ba12-c7626713d2cb
Set id: d709667e-ea4a-410b-91ec-a3320fa8c5d5
Version: 3
Effective Time: 20131031
 
Dorel Juvenile Group