Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID e11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d
Route
TOPICAL
Published
Effective Date 2025-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Benzoic Acid Camphor (synthetic) Chimonanthus Praecox Flower Oil Petrolatum Salicylic Acid Yellow Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Active ingredient Clotrimazole 1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

■ For the cure of:

   ■ athlete’s foot

   ■ jock itch

   ■ ringworm

■ Relieves:

   ■ itching

   ■ scaling

   ■ cracking

   ■ burning

   ■ discomfort

   ■ soreness

   ■ irritation

   ■ redness

Dosage and Administration

Directions

■ Adults and children 12 years of age or older:

      ■ Wash the affected area and dry thoroughly. In areas where the skin is thickened, soak in warm water to soften it first

      ■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.

      ■ For athlete’s foot:

         ■ Pay special attention to spaces between the toes. It is useful to apply at night on cotton balls wedged between the toes.

         ■ Wear well-fitting, ventilated shoes.

         ■ 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.

■ Children under 12 years: Do not use unless directed by a doctor

Description

Active ingredient Clotrimazole 1.0%

Section 44425-7

Other information

■ keep container tightly closed

■ store between 2º and 30º C (36º to 86º F)

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

■ irritation occurs

■ there is no improvement within

   ■ 2 weeks when used for jock itch

   ■ 4 weeks when used for athlete’s foot or ringworm

Section 50567-7

When using this product

■ avoid contact with the eyes

■ do not use the following on the skin:

   ■ soap

   ■ alcohol

   ■ hydrogen peroxide

   ■ iodine or sulphur compounds

Section 50570-1

Do not use

■ if pregnant

■ if nursing

■ on children under 12 years of age unless directed by a doctor

Section 51727-6

Inactive ingredients

Benzoic acid, camphor, chimonanthus praecox flower oil, petrolatum, salicylic acid, and yellow wax.

Section 51945-4

HUA TUO XIAN GAO ANTIFUNGAL OINTMENT

Clotrimazole 1.0%

Cure Athlete’s Foot Jock Itch & Ringworm

NDC 55614-650-01

20 g (0.7 oz)

Odorless

Non-Greasy

Section 53413-1

Questions or comments?

(888) 221-3496 M-F 9am-5pm

■ you may also report serious side effects to this phone number

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Clotrimazole 1.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

■ For the cure of:

   ■ athlete’s foot

   ■ jock itch

   ■ ringworm

■ Relieves:

   ■ itching

   ■ scaling

   ■ cracking

   ■ burning

   ■ discomfort

   ■ soreness

   ■ irritation

   ■ redness

Dosage and Administration (34068-7)

Directions

■ Adults and children 12 years of age or older:

      ■ Wash the affected area and dry thoroughly. In areas where the skin is thickened, soak in warm water to soften it first

      ■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.

      ■ For athlete’s foot:

         ■ Pay special attention to spaces between the toes. It is useful to apply at night on cotton balls wedged between the toes.

         ■ Wear well-fitting, ventilated shoes.

         ■ 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.

■ Children under 12 years: Do not use unless directed by a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

■ keep container tightly closed

■ store between 2º and 30º C (36º to 86º F)

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ irritation occurs

■ there is no improvement within

   ■ 2 weeks when used for jock itch

   ■ 4 weeks when used for athlete’s foot or ringworm

Section 50567-7 (50567-7)

When using this product

■ avoid contact with the eyes

■ do not use the following on the skin:

   ■ soap

   ■ alcohol

   ■ hydrogen peroxide

   ■ iodine or sulphur compounds

Section 50570-1 (50570-1)

Do not use

■ if pregnant

■ if nursing

■ on children under 12 years of age unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients

Benzoic acid, camphor, chimonanthus praecox flower oil, petrolatum, salicylic acid, and yellow wax.

Section 51945-4 (51945-4)

HUA TUO XIAN GAO ANTIFUNGAL OINTMENT

Clotrimazole 1.0%

Cure Athlete’s Foot Jock Itch & Ringworm

NDC 55614-650-01

20 g (0.7 oz)

Odorless

Non-Greasy

Section 53413-1 (53413-1)

Questions or comments?

(888) 221-3496 M-F 9am-5pm

■ you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Clotrimazole 1.0%


Advanced Ingredient Data


Raw Label Data

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