MetroLotion (Page 2 of 2)

ADVERSE REACTIONS

In a controlled clinical trial, safety data from 141 patients who used MetroLotion^® Topical Lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, MetroLotion^® Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, MetroLotion^® Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, MetroLotion^® Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), MetroLotion^® Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, MetroLotion^® Topical Lotion 4 (6%), lotion vehicle 0; dry skin, MetroLotion^® Topical Lotion 0, lotion vehicle 1 (l%); and worsening of rosacea, MetroLotion^® Topical Lotion 1 (1%), lotion vehicle 7 (10%).

The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea.

DOSAGE AND ADMINISTRATION

Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes.

Patients may use cosmetics after waiting for the MetroLotion^® Topical Lotion to dry (not less than 5 minutes).

HOW SUPPLIED

MetroLotion^® (metronidazole lotion) Topical Lotion, 0.75% is supplied in the following size:

2 fl. oz. (59 mL) plastic bottle — NDC 0299-3838-02

Storage: Store at controlled room temperature 68° to 77°F (20° — 25°C).

Protect from freezing.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Made in Canada
All trademarks are the property of their respective owners.
P53319-0
Revised: February 2017

PACKAGE LABEL

Rx only

NDC 0299-3838-02

MetroLotion^®

(metronidazole lotion)

TOPICAL LOTION 0.75%

2 FL OZ

(59 mL)

GALDERMA

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

Usual dosage: Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes.

Each Gram Contains: Active: metronidazole, 0.75% w/w (7.5 mg). Inactive: benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. See lot number and expiration date on bottom of carton.

Store at controlled room temperature 68º to 77ºF (20º – 25ºC).

Protect from freezing.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

All trademarks are the property of their respective owners.

P53320-0
Made in Canada

METROLOTION metronidazole lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-3838 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 7.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CYCLOMETHICONE GLYCERIN GLYCERYL MONOSTEARATE LIGHT MINERAL OIL PEG-100 STEARATE POLYETHYLENE GLYCOL 400 POTASSIUM SORBATE WATER STEARETH-21 STEARYL ALCOHOL SODIUM HYDROXIDE LACTIC ACID, UNSPECIFIED FORM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0299-3838-02 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 59 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0299-3838-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020901 11/24/1998

Labeler — Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Operations
G Production Inc.		251676961	manufacture (0299-3838)

Establishment
Name	Address	ID/FEI	Operations
DPT Laboratories, Ltd.		832224526	manufacture (0299-3838)

Revised: 06/2018 Galderma Laboratories, L.P.