LUXURY ANTISEPTIC WITH WINTERGREEN- isopropyl alcohol solution

Luxury by

Drug Labeling and Warnings

Luxury by is a Otc medication manufactured, distributed, or labeled by TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, FD&C green #3, FD&C yellow #5, methyl salicylate

Principal Display Panel

INGREDIENTS AND APPEARANCE

LUXURY  ANTISEPTIC WITH WINTERGREEN
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76772-036
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
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYL SALICYLATE (UNII: LAV5U5022Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76772-036-35	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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)

Establishment
Name	Address	ID/FEI	Business Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI		533120570	manufacture(76772-036)