MERTHIOLATE- benzalkonium chloride cream

Merthiolate by

Drug Labeling and Warnings

Merthiolate by is a Otc medication manufactured, distributed, or labeled by Caribe Natural, Inc, World Perfumes, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                            Purpose

Benzalkonium Chloride 0.13%          First Aid Antiseptic

PURPOSE

Use first aid to help prevent skin infection in 

• minor cuts
• scrapes
• burns

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Merthiolate Tincture

Mercury Free

First Aid Antiseptic

For External Use Only

DOSAGE & ADMINISTRATION

Directions

• clean the affected area
• apply a small amount on the area 1 to 3 times daily
• may be covered by a sterile bandage
• if bandaged, let dry first

WARNINGS

Warnings

• For external use only
• Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
• When using this product
• do not use in eyes or 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

INACTIVE INGREDIENT

Inactive Ingredients alcohol, acetone, purified water, FD&C red #22

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MERTHIOLATE 
benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59561-709
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 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59561-709-01	30 g in 1 PACKAGE; 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	05/05/2015

Labeler - Caribe Natural, Inc (624210480)

Establishment
Name	Address	ID/FEI	Business Operations
World Perfumes, Inc		101312044	manufacture(59561-709)