ECOZA (Page 3 of 3)

Instructions for Use ECOZA ® (ee-ko-zah) (econazole nitrate) topical foam, 1%

Important information: Ecoza topical foam is for use on skin only.

Do not use Ecoza topical foam in your eyes or vagina.

Parts of Ecoza topical foam Canister. (See Figure A)

Figure A
(click image for full-size original)
Figure A

How to apply Ecoza topical foam:

Step 1: Before you apply Ecoza topical foam, shake the Ecoza topical foam canister for about 5 seconds.
Step 2: Remove the cap and turn the Ecoza topical foam canister upside down over the palm of your hand.
Step 3: Press down firmly on the actuator until there is a small amount of foam about the size of a golf ball in the palm of your hand. (See Figures B and C)
Figure BFigure C
Figure B Figure C
Step 4: Use your finger-tips to scoop up small amounts of Ecoza topical foam and apply to the affected skin areas on your feet. Gently rub the foam into the skin. (See Figure D)

Figure D

Figure D
Step 5: You should apply Ecoza topical foam to your toes, to the spaces between your toes, and to the surrounding areas 1 time a day for 4 weeks or as prescribed by your doctor.
Step 6: Replace the cap. Wash your hands after applying Ecoza topical foam.

How should I store Ecoza topical foam?

  • Store Ecoza topical foam at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Do not refrigerate or freeze Ecoza topical foam.
  • Do not store Ecoza topical foam in direct sunlight.
  • Ecoza topical foam is flammable. Keep the Ecoza topical foam canister away from heat and temperatures above 120°F (49°C), even if the canister is empty.
  • Do not puncture or burn the Ecoza topical foam canister.

Keep Ecoza topical foam and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for Exeltis USA Dermatology, LLC Florham Park, NJ 07932

Issued: 07/2016

PRINCIPAL DISPLAY PANEL — 70 g Canister Label

NDC 23710-100-70

ecoza™
(econazole nitrate)
topical foam, 1%

For Topical Use Only

Not for ophthalmic, oral or intravaginal use.

Keep Out of Reach of Children

Rx Only
Net Wt 70g

Exeltis Rethinking healthcare

PRINCIPAL DISPLAY PANEL -- 70 g Canister Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 70 g Canister Carton

NDC 23710-100-70

ecoza™
(econazole nitrate)
topical foam, 1%

For Topical Use Only

Not for ophthalmic, oral
or intravaginal use.

Keep Out of Reach of Children

Rx Only
Net Wt 70g

Exeltis Rethinking healthcare

PRINCIPAL DISPLAY PANEL -- 70 g Canister Carton
(click image for full-size original)
ECOZA econazole nitrate aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23710-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ECONAZOLE NITRATE (ECONAZOLE) ECONAZOLE NITRATE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
GLYCERIN
POLYSORBATE 20
POVIDONE K30
PROPYLENE GLYCOL
STEARIC ACID
TROLAMINE
WATER
BUTANE
Product Characteristics
Color white (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23710-100-70 1 CANISTER in 1 CARTON contains a CANISTER
1 70 g in 1 CANISTER This package is contained within the CARTON (23710-100-70)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205175 10/02/2020
Labeler — Exeltis USA Dermatology, LLC (078715346)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 analysis (23710-100), label (23710-100), manufacture (23710-100), pack (23710-100)

Revised: 01/2022 Exeltis USA Dermatology, LLC

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