SPL v1
SPL
SPL Set ID 43a5b3c8-3b99-b113-e063-6394a90a9aff
Route
TOPICAL
Published
Effective Date 2025-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (10 g)
Inactive Ingredients
Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-15

Description

GLYCERIN 10g

Purpose

Antifungal (for the treatment of fungal skin infections)

Dosage and Administration

Clean and dry the affected area thoroughly. Apply a thin layer of the cream to the affected skin and surrounding area twice daily (morning and evening) or as directed by a doctor. Continue use for 1-2 weeks after symptoms disappear to prevent recurrence.


Medication Information

Purpose

Antifungal (for the treatment of fungal skin infections)

Dosage and Administration

Clean and dry the affected area thoroughly. Apply a thin layer of the cream to the affected skin and surrounding area twice daily (morning and evening) or as directed by a doctor. Continue use for 1-2 weeks after symptoms disappear to prevent recurrence.

Description

GLYCERIN 10g

Warnings

1. For external use only.2. Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.3. Do not use on broken or irritated skin.4. If irritation, redness, swelling, or itching worsens, discontinue use and consult a doctor.5. If condition persists after 4 weeks of use, consult a doctor.6. Do not use if you are allergic to any ingredient in this product.7. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Use

Stop use and ask a doctor if:- Irritation, burning, stinging, or redness occurs and persists.- The infection spreads or worsens.- New symptoms appear.- Condition does not improve after 4 weeks of treatment.

Do Not Use

- Do not use on children under 2 years of age unless directed by a doctor.- Do not use for vaginal yeast infections or nail fungal infections.- Do not use if the product is expired or the packaging is damaged.

When Using Section

1. Use only as directed.2. Do not cover the treated area with bandages or dressings unless directed by a doctor.3. Avoid using other topical products on the same area unless advised by a doctor.4. If using for athlete's foot, wear well-fitting, ventilated shoes and change socks daily.5. For jock itch, wear loose-fitting, breathable clothing.

Inactive Ingredients

WATER, PROPYLENE GLYCOL, HELIANTHUS ANNUUS(SUNFLOWER)SEED OlL,chamomile extract,Cetearyl Alcohol,ETHYLHEXYLPALMITATEBUTYROSPERMUM PARKII (SHEA) BUTTER, 1,2-HEXANEDIOLHYDROXYACETOPHENONE, Cetearyl Glucoside, TOCOPHERYL ACETATECARBOMER, TRIETHANOLAMINE, MENTHOLUM, SOPHORAFLAVESCENSEXTRACT, ARTEMISIA ARGYI LEAF EXTRACT, GLYCYRRHIZAURALENSIS(LICORICE) EXTRACT, SODIUM HYALURONATE, OLIGOPEPTIDE-1

​active Ingredients

GLYCERIN 10g

Principal Display Panel

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.

Uses[indications & Usage Section]

For the treatment of superficial fungal infections of the skin such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by susceptible fung


Structured Label Content

Purpose

Antifungal (for the treatment of fungal skin infections)

Warnings

1. For external use only.2. Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.3. Do not use on broken or irritated skin.4. If irritation, redness, swelling, or itching worsens, discontinue use and consult a doctor.5. If condition persists after 4 weeks of use, consult a doctor.6. Do not use if you are allergic to any ingredient in this product.7. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Use (stop use)

Stop use and ask a doctor if:- Irritation, burning, stinging, or redness occurs and persists.- The infection spreads or worsens.- New symptoms appear.- Condition does not improve after 4 weeks of treatment.

Do Not Use (Do not use)

- Do not use on children under 2 years of age unless directed by a doctor.- Do not use for vaginal yeast infections or nail fungal infections.- Do not use if the product is expired or the packaging is damaged.

When Using Section (When using section)

1. Use only as directed.2. Do not cover the treated area with bandages or dressings unless directed by a doctor.3. Avoid using other topical products on the same area unless advised by a doctor.4. If using for athlete's foot, wear well-fitting, ventilated shoes and change socks daily.5. For jock itch, wear loose-fitting, breathable clothing.

Inactive Ingredients (Inactive ingredients)

WATER, PROPYLENE GLYCOL, HELIANTHUS ANNUUS(SUNFLOWER)SEED OlL,chamomile extract,Cetearyl Alcohol,ETHYLHEXYLPALMITATEBUTYROSPERMUM PARKII (SHEA) BUTTER, 1,2-HEXANEDIOLHYDROXYACETOPHENONE, Cetearyl Glucoside, TOCOPHERYL ACETATECARBOMER, TRIETHANOLAMINE, MENTHOLUM, SOPHORAFLAVESCENSEXTRACT, ARTEMISIA ARGYI LEAF EXTRACT, GLYCYRRHIZAURALENSIS(LICORICE) EXTRACT, SODIUM HYALURONATE, OLIGOPEPTIDE-1

​active Ingredients (​Active ingredients)

GLYCERIN 10g

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dosage and Administration (Dosage and administration)

Clean and dry the affected area thoroughly. Apply a thin layer of the cream to the affected skin and surrounding area twice daily (morning and evening) or as directed by a doctor. Continue use for 1-2 weeks after symptoms disappear to prevent recurrence.

Keep Out of Reach of Children. (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.

Uses[indications & Usage Section] (Uses[INDICATIONS & USAGE SECTION])

For the treatment of superficial fungal infections of the skin such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by susceptible fung


Advanced Ingredient Data


Raw Label Data

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