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

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 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

Package Label

ALCOHOL WIPE
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50428-0030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	.70 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50428-0030-5	1 in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/20/2010

Labeler - Dorel Juvenile Group (118841501)

Name	Address	ID/FEI	Business Operations
Establishment
Shanghai Yinjin Medical Supplies Co. Ltd		530501535	MANUFACTURE(50428-0030)