WHITE MERTODOL- 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.

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White Mertodol

Active Ingredient

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

Consult a doctor in case of * deep puncture
wounds * animal bites * serious burns

Stop use and consult a doctor if the condition

persists or gets worse

Keep out of the reach of children. In case of

accidental ingestion, seek professional assistance

or contact a Poison Control Center immediately.

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, water

Questions

(33) 3617 5010 (In Guadalajara, Jal. Mexico)

White Mertodol

image description

WHITE MERTODOL
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65055-302
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)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65055-302-02	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(65055-302)

Revised: 7/2023

Document Id: 0022e63f-6131-29f0-e063-6294a90aff98

Set id: 8e3f62c2-298b-4d82-b72c-a9b785add322

Version: 2

Effective Time: 20230710

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