Ezri Care Tm

Ezri Care Tm
SPL v1
SPL
SPL Set ID f990672c-d959-38f2-e053-6394a90a8025
Route
TOPICAL
Published
Effective Date 2023-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Cetostearyl Alcohol Chlorocresol Edetate Disodium Light Mineral Oil Polyoxyl 20 Cetostearyl Ether Propylene Glycol Water Sodium Phosphate, Dibasic, Dihydrate Sodium Phosphate, Monobasic, Dihydrate White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-08-19

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Uses

• For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)

• Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

Section 42229-5

Cures Most Athlete's Foot

Compared to the active ingredient in Micatin ®*

Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Micatin ®

Distributed by:

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Made in India

Section 50565-1

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

Warnings

For external use only

Do not use • on children under 2 years of age unless directed by a doctor • for diaper rash

When using this product • avoid contact with the eyes

Stop use and ask a doctor if • irritation occurs • there is no improvement within 2 weeks when used for the treatment of jock itch • there is no improvement within 4 weeks when used for athlete’s foot or ringworm

Packaging

Directions

• Clean the affected area and dry thoroughly. Apply a thin layer of cream over affected area twice daily (morning and night) or as directed by a doctor • Supervise children in the use of this product • For athlete’s foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily • For athlete’s foot and ringworm, use daily for 4 weeks • For jock itch, use daily for 2 weeks • If condition persists longer, consult a doctor. • This product is not effective on the scalp or nails

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Other Information

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum

Questions Or Comments?

718-502-6610 between 9 am to 4 pm EST, Monday-Friday.


Structured Label Content

Uses

• For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)

• Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

Section 42229-5 (42229-5)

Cures Most Athlete's Foot

Compared to the active ingredient in Micatin ®*

Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Micatin ®

Distributed by:

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Made in India

Section 50565-1 (50565-1)

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

Purpose

Antifungal

Warnings

For external use only

Do not use • on children under 2 years of age unless directed by a doctor • for diaper rash

When using this product • avoid contact with the eyes

Stop use and ask a doctor if • irritation occurs • there is no improvement within 2 weeks when used for the treatment of jock itch • there is no improvement within 4 weeks when used for athlete’s foot or ringworm

Packaging

Directions

• Clean the affected area and dry thoroughly. Apply a thin layer of cream over affected area twice daily (morning and night) or as directed by a doctor • Supervise children in the use of this product • For athlete’s foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily • For athlete’s foot and ringworm, use daily for 4 weeks • For jock itch, use daily for 2 weeks • If condition persists longer, consult a doctor. • This product is not effective on the scalp or nails

Drug Facts

Active Ingredient (Active ingredient)

Miconazole Nitrate 2%

Other Information (Other information)

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum

Questions Or Comments? (Questions or comments?)

718-502-6610 between 9 am to 4 pm EST, Monday-Friday.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)