MERTODOL SOLUTION- benzalkonium chloride spray
Laboratorios Jaloma, S.A. de C.V.

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.

----------

Mertodol solution

Active Ingridients

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

First aid to help prevent infection in *minor cuts *scrapes *burns

Warnings

-For external use only

-Do not use in the eyes or apply over large areas of the body

Consult a doctor in case of

- deep or puncture wounds

-animal bites

-serious burns

-Stop use and consult a doctor if the condition persist or gets worse

-do not use longer than 1 week, unless directed by a doctor

Keep out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediatley.

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

Inactive Ingredients

Acetone, Alcohol, d & c red No. 22, water.

Labels

image description

MERTODOL SOLUTION
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65055-202
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65055-202-02	40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/21/2016	10/21/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/21/2016	10/21/2016

Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)

Name	Address	ID/FEI	Business Operations
Establishment
Laboratorios Jaloma, S.A. de C.V.		811122357	manufacture(65055-202)

Revised: 7/2023

Document Id: 0022e63f-612f-29f0-e063-6294a90aff98

Set id: b0326803-dcad-4afc-9fa1-755ffbd6b58f

Version: 2

Effective Time: 20230710

Laboratorios Jaloma, S.A. de C.V.