Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID de75179d-1889-4823-9f39-4bebdf185d76
Route
TOPICAL
Published
Effective Date 2013-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Glycerin Glyceryl Stearate Se Laureth-23 Methylparaben Mineral Oil Petrolatum Propylparaben Stearic Acid Stearyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-01

Description

glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water Inactive Ingredients


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

on the scalp or nails

When using this product

avoid contact with eyes

Indications and Usage

  relieves itching, burning, cracking, scaling and discomfort associated with: Uses

-athletes foot      -jock itch      -ring worm



Dosage and Administration

Directions

-wash and dry affected area thoroughly

-apply a thin layer to affected area 2 times daily

-for athlete's foot and ringworm, use daily for up to 4 weeks

-for jock itch, use daily for up to 2 weeks

Description

glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water Inactive Ingredients

Section 50565-1

. If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

Section 51727-6

glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water Inactive Ingredients

Section 51945-4

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active Ingredient

Clotrimazole 1%


Structured Label Content

Indications and Usage (34067-9)

  relieves itching, burning, cracking, scaling and discomfort associated with: Uses

-athletes foot      -jock itch      -ring worm



Dosage and Administration (34068-7)

Directions

-wash and dry affected area thoroughly

-apply a thin layer to affected area 2 times daily

-for athlete's foot and ringworm, use daily for up to 4 weeks

-for jock itch, use daily for up to 2 weeks

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

on the scalp or nails

When using this product

avoid contact with eyes

Section 50565-1 (50565-1)

. If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

Section 51727-6 (51727-6)

glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water Inactive Ingredients

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active Ingredient

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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