LUXURY ANTISEPTIC- isopropyl alcohol solution
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED 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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Luxury 70% Isopropyl Alcohol

Active ingredient

Isopropyl Alcohol 70%

Purpose

First Aid Antiseptic

Uses

First aid to help prevent the risk of infection in:

minor cuts
scrapes
burns

Warnings

For external use only.

If taken internally serious gastric

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

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

When using this product

do not get into eyes
do not inhale
do not apply over large areas of the body
do not use longer than 1 week

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 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

Inactive ingredient

purified water

Principal Display Panel

LUXURY ANTISEPTIC
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76772-024
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 in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76772-024-47	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/10/2021

Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Name	Address	ID/FEI	Business Operations
Establishment
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI		533120570	manufacture(76772-024)