TINTUTA DE MENTIOLATE/MENTHIOLATE TINCTURE- benzalkonium chloride solution

Tintuta de Mentiolate/Menthiolate Tincture by

Drug Labeling and Warnings

Tintuta de Mentiolate/Menthiolate Tincture by is a Otc medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, World Perfume, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                   Purpose

Benzalkonium Chloride (0.13%) ................... Antiseptic

PURPOSE

Use

May help prevent skin infection in

• minor cuts
• scrapes 
• burns

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Antiseptic

For External Use Only

DOSAGE & ADMINISTRATION

Directions

• clean the affected area
• and dry thoroughly. Apply a thin layer 1 to 3 times daily.
• May be covered with a sterile bandage, let dry first.

WARNINGS

Warnings For external use only

Avoid Contact with eyes.

When using this product

INACTIVE INGREDIENT

Inactive Ingredients Acetone, FD&C red # 22, Isopropyl Alcohol, Purified Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTUTA DE MENTIOLATE/MENTHIOLATE TINCTURE 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETONE (UNII: 1364PS73AF)
ALCOHOL (UNII: 3K9958V90M)
D&C RED NO. 22 (UNII: 1678RKX8RT)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-128-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2015

Labeler - Dannso Corp./d.b.a. Essential Products (059741071)

Registrant - Dannso Corp./d.b.a. Essential Products (059741071)

Establishment
Name	Address	ID/FEI	Business Operations
Dannso Corp./d.b.a. Essential Products		059741071	LABEL(70242-128)

Establishment
Name	Address	ID/FEI	Business Operations
World Perfume, Inc		101312044	MANUFACTURE(70242-128)