Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 840364aa-d799-4163-a9e8-3f10c18f86ae
Route
TOPICAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Cetostearyl Alcohol Ethylparaben Glycerin Light Mineral Oil Propylene Glycol Sodium Sulfite Steareth-20 Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-06

Description

Active ingredient Miconazole nitrate 2.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

cures most jock itch (tinea cruris)


relieves the following symptoms associated with jock itch:

   itching

   scaling

   cracking

   burning

   discomfort

   soreness

   irritation

   redness

Dosage and Administration

Directions

Adults and children 2 years of age or older:


   wash the affected area and dry thoroughly


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

   supervise children in the use of this product


   use daily for 2 weeks


   if condition persists longer, consult a doctor


   this product is not effective on the scalp or nails

Children under 2 years: do not use unless directed by a doctor

Description

Active ingredient Miconazole nitrate 2.0%

Section 44425-7

Other information

keep container tightly closed


store between 15 and 30 C (59 to 86 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

Section 50567-7

When using this product


avoid contact with the eyes

Section 50570-1

Do not use


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

Section 51727-6

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, sodium sulfite, steareth-20, stearic acid, and water

Section 51945-4

PerfectHeal Antifungal

Clotrimazole 1%

Antifungal Cream

Net Wt. 10 g (1/3 oz)

NDC 69070-303-01

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

Miconazole nitrate 2.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

cures most jock itch (tinea cruris)


relieves the following symptoms associated with jock itch:

   itching

   scaling

   cracking

   burning

   discomfort

   soreness

   irritation

   redness

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age or older:


   wash the affected area and dry thoroughly


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

   supervise children in the use of this product


   use daily for 2 weeks


   if condition persists longer, consult a doctor


   this product is not effective on the scalp or nails

Children under 2 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 15 and 30 C (59 to 86 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

Section 50567-7 (50567-7)

When using this product


avoid contact with the eyes

Section 50570-1 (50570-1)

Do not use


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

Section 51727-6 (51727-6)

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, sodium sulfite, steareth-20, stearic acid, and water

Section 51945-4 (51945-4)

PerfectHeal Antifungal

Clotrimazole 1%

Antifungal Cream

Net Wt. 10 g (1/3 oz)

NDC 69070-303-01

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

Miconazole nitrate 2.0%


Advanced Ingredient Data


Raw Label Data

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