Abutol by Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi Abutol PARIS 

Abutol by

Drug Labeling and Warnings

Abutol by is a Otc medication manufactured, distributed, or labeled by Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ABUTOL ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid 
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi

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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Abutol PARIS 

Drug Facts

Active Ingredient

Isopropyl alcohol 70%

Purpose

First Aid Antiseptic

Use first aid to help prevent the risk of infection in:

minor cuts  scrapes  burns

Warning

For external use only

Flammable  keep away from fire or flame, heat, spark, electrical.

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

When using this product  do not get into eyes  do not apply over large areas of the body  do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if condition persists or gets worse

Caution: Do body not apply to irritated skin or if excessive irritation develops. Avoid inhaling this product. 

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions  clean the affected area  apply a small amount of this product on the affected area 1 to 3 times daily  may be covered with a sterile bandage  if bandaged, let dry first.

Other Information  does not contain, nor is intended as a substitute for grain or ethyl alcohol  will produce serious gastric disturbances if taken internally

Inactive Ingredient water

Distributed by: Kanar Inc. Carltadt, NJ 07072

You may also report any serious side effects to PO Box 328, Wood Ridge, NJ 07075-328

Made in Turkey

Packaging

ABUTOL  ISOPROPYL RUBBING ALCOHOL
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78089-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78089-029-01	1 in 1 CARTON	07/21/2020	05/01/2021
1		473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 78089-029-02	1 in 1 CARTON	07/21/2020	05/01/2021
2		3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/21/2020	05/01/2021

Labeler - Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi (565678914)

Establishment
Name	Address	ID/FEI	Business Operations
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi		565678914	manufacture(78089-029)

Revised: 7/2021

Document Id: f6df0c84-e4bf-4317-9ec1-ac7180fbbedc

34390-5

Set id: b0cc1339-efe1-43fd-a0ce-a189ef0a5c1a

Version: 2

Effective Time: 20210708

 

Endek