172 Remedy Clinical Antifungal Ointment

172 Remedy Clinical Antifungal Ointment
SPL v3
SPL
SPL Set ID dad58efb-cc20-577a-e053-2a95a90abd9d
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Green Tea Leaf Carboxymethylcellulose 7-dehydrocholesterol Medium-chain Triglycerides Dimethicone Clove Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Glycerin Petrolatum Hydrogenated Soybean Lecithin Alpha-tocopherol Acetate Yeast, Unspecified Corn Oil Aphanizomenon Flosaquae Olive Oil Water Safflower Seed Oil Polyglyceryl-6 Esters

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Miconazole nitrate 2.0% w/w

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 2.0% w/w

Uses
  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Warnings

For external use only.

Directions
  • clean the affected area and dry thoroughly
  • apply a thin layer of ointment 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
Do Not Use
  • on children under 2 years of age unless directed by a doctor
  • on scalp or nails
Package Label

Active Ingredient

Miconazole nitrate 2.0% w/w

Other Information
  • protect from freezing
  • avoid excessive heat
Inactive Ingredient

7-dehydrocholesterol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea (olive) fruit oil, petrolatum, phospholipids, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil

When Using This Product
  • avoid contact with eyes
Manufacturing Information

www.medline.com

©2022 Medline and Medline Remedy are

registered trademarks of Medline Industries, LP.

Made in the USA of domestic and imported materials

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

REF: MSC092625

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm
  • there is no improvement within 2 weeks for jock itch
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Purpose

Antifungal

Warnings

For external use only.

Directions
  • clean the affected area and dry thoroughly
  • apply a thin layer of ointment 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
Do Not Use (Do not use)
  • on children under 2 years of age unless directed by a doctor
  • on scalp or nails
Package Label

Active Ingredient (Active ingredient)

Miconazole nitrate 2.0% w/w

Other Information (Other information)
  • protect from freezing
  • avoid excessive heat
Inactive Ingredient (Inactive ingredient)

7-dehydrocholesterol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea (olive) fruit oil, petrolatum, phospholipids, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil

When Using This Product (When using this product)
  • avoid contact with eyes
Manufacturing Information

www.medline.com

©2022 Medline and Medline Remedy are

registered trademarks of Medline Industries, LP.

Made in the USA of domestic and imported materials

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

REF: MSC092625

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm
  • there is no improvement within 2 weeks for jock itch
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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