76986-020 Gembooxt Ringworm Cream

76986-020 Gembooxt Ringworm Cream
SPL v1
SPL
SPL Set ID 464a33c3-6d16-0cfd-e063-6294a90abf4b
Route
TOPICAL
Published
Effective Date 2025-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (0.02 g) Hydrocortisone (0.003 g)
Inactive Ingredients
Stearic Acid Ethylhexyl Palmitate Gentiana Scabra Whole Glyceryl Stearate Glycerin Mineral Oil Ascorbyl Palmitate Glyceryl Caprylate Centella Asiatica Triterpenoids Water Dibasic Potassium Phosphate Xanthan Gum Pentylene Glycol Camphor (synthetic) Lactobacillus Reuteri F275 Strain Hydroxyphenyl Propamidobenzoic Acid Rosa Rugosa Flower 1,2-hexanediol Allantoin Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Ethylhexylglycerin Potassium Lauryl Phosphate Triethanolamine Cetyl Alcohol Stearyl Alcohol Ceteareth-25 Menthol Oat Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-19

Description

Miconazole Nitrate (2%) Hydrocortisone (0.3%)


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage



Cures most athlete's foot between the toes.

Effectiveness on the bottom or sides of foot is unknown

Cures most jock itch and ringworm.

Relieves itching, burning, cracking, and scaling which accompany these conditions.

Dosage and Administration



For adults and children 12 years and older.

1. Wash and dry the affected area before application.

2. Athlete's Foot (between toes): Apply a thin layer to the affected area between and around the toes. Use twice daily(morning and night) for 1 week, or once daily for 2 weeks.or as directed by a doctor. Wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

3. Jock ltch and Ringworm: Apply a thin layer to the affectedarea once daily for 1 week, or as directed by a doctor.

4. Wash hands after use.

Children under 12 years: Ask a doctor.

Description

Miconazole Nitrate (2%) Hydrocortisone (0.3%)

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison control center immediately

Section 50566-9

Stop using and ask a doctor if too much irritation occurs or irritation gets worse.

Section 50567-7



Ask a doctor before use if pregnant or nursing.

When using this product, avoid contact with eyes, nose and mouth. lf contact occurs, rinse thoroughly with water

Section 50570-1



Do not use on nails or scalp

Do not use if allergic to any ingredients in this product

Do not use in or near the mouth or the eyes.

Do not use for vaginal yeast infections

Section 51727-6

CETYL ALCOHOL

STEARYL ALCOHOL

GLYCERYL STEARATE

GLYCERIN

MINERAL OIL

CETEARETH-25

ETHYLHEXYL PALMITATE

CAMPHOR

MENTHOLUM

GENTIANA SCABRA EXTRACT

CENTELLA ASIATICA EXTRACT

AVENA SATIVA (OAT) KERNEL EXTRACT

ROSA RUGOSA FLOWER EXTRACT

LACTOBACILLUS FERMENT

DIMETHICONE

GLYCERYL CAPRYLATE

ETHYLHEXYLGLYCERIN

1,2-HEXANEDIOL

ALLANTOIN

POTASSIUM LAURYL PHOSPHATE

DIPOTASSIUM PHOSPHATE

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

XANTHAN GUM

BUTYLENE GLYCOL

PENTYLENE GLYCOL

HYDROXYPHENYL PROPAMIDOBENZOIC ACID

ASCORBYL PALMITATE

TRIETHANOLAMINE

Section 51945-4

Section 55105-1

Antifungal, Anti-ltch

Section 55106-9

Miconazole Nitrate (2%)

Hydrocortisone (0.3%)


Structured Label Content

Indications and Usage (34067-9)



Cures most athlete's foot between the toes.

Effectiveness on the bottom or sides of foot is unknown

Cures most jock itch and ringworm.

Relieves itching, burning, cracking, and scaling which accompany these conditions.

Dosage and Administration (34068-7)



For adults and children 12 years and older.

1. Wash and dry the affected area before application.

2. Athlete's Foot (between toes): Apply a thin layer to the affected area between and around the toes. Use twice daily(morning and night) for 1 week, or once daily for 2 weeks.or as directed by a doctor. Wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

3. Jock ltch and Ringworm: Apply a thin layer to the affectedarea once daily for 1 week, or as directed by a doctor.

4. Wash hands after use.

Children under 12 years: Ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison control center immediately

Section 50566-9 (50566-9)

Stop using and ask a doctor if too much irritation occurs or irritation gets worse.

Section 50567-7 (50567-7)



Ask a doctor before use if pregnant or nursing.

When using this product, avoid contact with eyes, nose and mouth. lf contact occurs, rinse thoroughly with water

Section 50570-1 (50570-1)



Do not use on nails or scalp

Do not use if allergic to any ingredients in this product

Do not use in or near the mouth or the eyes.

Do not use for vaginal yeast infections

Section 51727-6 (51727-6)

CETYL ALCOHOL

STEARYL ALCOHOL

GLYCERYL STEARATE

GLYCERIN

MINERAL OIL

CETEARETH-25

ETHYLHEXYL PALMITATE

CAMPHOR

MENTHOLUM

GENTIANA SCABRA EXTRACT

CENTELLA ASIATICA EXTRACT

AVENA SATIVA (OAT) KERNEL EXTRACT

ROSA RUGOSA FLOWER EXTRACT

LACTOBACILLUS FERMENT

DIMETHICONE

GLYCERYL CAPRYLATE

ETHYLHEXYLGLYCERIN

1,2-HEXANEDIOL

ALLANTOIN

POTASSIUM LAURYL PHOSPHATE

DIPOTASSIUM PHOSPHATE

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

XANTHAN GUM

BUTYLENE GLYCOL

PENTYLENE GLYCOL

HYDROXYPHENYL PROPAMIDOBENZOIC ACID

ASCORBYL PALMITATE

TRIETHANOLAMINE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal, Anti-ltch

Section 55106-9 (55106-9)

Miconazole Nitrate (2%)

Hydrocortisone (0.3%)


Advanced Ingredient Data


Raw Label Data

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