MERTHIOLATE- benzalkonium chloride cream 
Caribe Natural, Inc

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.

----------

Active Ingredients                                            Purpose

Benzalkonium Chloride 0.13%          First Aid Antiseptic

Use first aid to help prevent skin infection in 

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

Merthiolate Tincture

Mercury Free

First Aid Antiseptic

For External Use Only

Directions

Warnings

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

label image

MERTHIOLATE 
benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-709
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ACETONE (UNII: 1364PS73AF)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59561-709-0130 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/05/2015
Labeler - Caribe Natural, Inc (624210480)
Establishment
NameAddressID/FEIBusiness Operations
World Perfumes, Inc101312044manufacture(59561-709)

Revised: 5/2015
Document Id: 5b42c72b-3a74-43eb-b34a-bb061ec026de
Set id: 98c22e08-638a-4400-9736-daf0be75ed47
Version: 1
Effective Time: 20150505
 
Caribe Natural, Inc