ACETONE ISOPROPYL ALCOHOL- isopropyl alcohol swab
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.

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

Active Ingredients

Isopropyl Alcohol 70%

Purpose

Antiseptic

Use

For use where topical defatting or cleansing is required.

Warnings

For external use only

Flammable, keep away from fire or flame

Do Not Use

with electrocautery procedures

in the eyes, if contact occurs, flush eyes with water

Keep out of reach of children

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

Directions

Apply to intended area as needed. Discard after single use.

Other Information

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

Inactive Ingredient

Acetone, Purified Water

Package Label

Pouch Label

ACETONE ISOPROPYL ALCOHOL
isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:34645-2325
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACETONE (UNII: 1364PS73AF)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:34645-2325-3	2.5 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package	01/01/2010	08/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2010	08/21/2018

Labeler - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.		530968767	manufacture(34645-2325)

Revised: 8/2018

Document Id: 73f07429-861d-5aab-e053-2a91aa0a0edf

Set id: a78ede0c-0e04-453a-be01-2491f0c614cb

Version: 5

Effective Time: 20180821

Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.