Private Label Antifungal Barrier Cream

Private Label Antifungal Barrier Cream
SPL v1
SPL
SPL Set ID 2ee40c37-504b-43ed-960a-535015407492
Route
TOPICAL
Published
Effective Date 2025-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (200 g)
Inactive Ingredients
Water Allantoin Phenoxyethanol Ethylhexylglycerin Petrolatum Dimethicone 1000 Beeswax Hydrogenated Castor Oil Zinc Oxide Isopropyl Palmitate Cetyl Dimethicone 25 Cetyl Peg/ppg-10/1 Dimethicone (hlb 5)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-09

Description

For external use only. Not intended for ingestion. Do not use on children under 2 year of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the prevention of athlete’s foot: if irritation occurs, discontinue use and consult a doctor. Do not use for diaper rash. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

For external use only. Not intended for ingestion. Do not use on children under 2 year of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the prevention of athlete’s foot: if irritation occurs, discontinue use and consult a doctor. Do not use for diaper rash. If swallowed, get medical help or contact a Poison Control Center right away.

Labeling

Warnings

For external use only. Not intended for ingestion. Do not use on children under 2 year of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the prevention of athlete’s foot: if irritation occurs, discontinue use and consult a doctor. Do not use for diaper rash. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily as directed by a doctor or health care professional. 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.

Questions?

Call toll free 1-866-416-2366

Active Ingredients

Miconazole Nitrate 2.0%

Indications & Uses

Proven clinically effective in the treatment of most athlete’s foot (tinea pedia), jock itch (tinea cruris) and ringworm (tinea corporis). For the treatment of superficial skin infections caused by yeast (candida albicans). For effective relief of redness, irritation, scaling, itching, discomfort and burning.

Inactive Ingredients

Allantoin, bees wax, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, ethylhexylglycerin, fragrance, hydrogenated castor oil, isopropyl palmitate, petrolatum, phenoxyethanol, purified water, sodium chloride, zinc oxide

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Purpose

Antifungal

Labeling

Warnings

For external use only. Not intended for ingestion. Do not use on children under 2 year of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the prevention of athlete’s foot: if irritation occurs, discontinue use and consult a doctor. Do not use for diaper rash. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily as directed by a doctor or health care professional. 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.

Questions?

Call toll free 1-866-416-2366

Active Ingredients

Miconazole Nitrate 2.0%

Indications & Uses

Proven clinically effective in the treatment of most athlete’s foot (tinea pedia), jock itch (tinea cruris) and ringworm (tinea corporis). For the treatment of superficial skin infections caused by yeast (candida albicans). For effective relief of redness, irritation, scaling, itching, discomfort and burning.

Inactive Ingredients (Inactive ingredients)

Allantoin, bees wax, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, ethylhexylglycerin, fragrance, hydrogenated castor oil, isopropyl palmitate, petrolatum, phenoxyethanol, purified water, sodium chloride, zinc oxide

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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