Drug Facts 62654-147

Drug Facts 62654-147
SPL v3
SPL
SPL Set ID 69c5340d-9abd-43bf-a90b-9568d615f06f
Route
TOPICAL
Published
Effective Date 2018-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Aloe Vera Leaf Cetostearyl Alcohol Cyclomethicone 5 Dmdm Hydantoin Iodopropynyl Butylcarbamate Glycerin Glyceryl Monostearate Peg-100 Stearate Isopropyl Palmitate Polyquaternium-37 (10000 Mpa.s) Propylene Glycol Dicaprylate Propylene Glycol Dicaprylate/dicaprate Ppg-1 Trideceth-6 Propylene Glycol Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-10

Description

Active Ingredients Miconazole Nitrate 2%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

Treats most jock itch, ringworm and athlete's foot

Dosage and Administration

Directions

Cleanse the affected area and dry thoroughly.

Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician. Supervise children in the use of this product.

Athlete's foot

Pay special attention to the spaces between toes

wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Athlete's foot and ringworm

use daily for 4 weeks

Jock Itch

use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp or nails.



Description

Active Ingredients Miconazole Nitrate 2%

Section 44425-7

Other Information

Store at 59-86 F (15-30 C)

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

If irritation occurs or if there is no improvement withing 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch, discontinue use and consult a doctor.

Section 50570-1

Do not use on children under 2 years of age for diaper rash.

Section 51727-6

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cyclopentasiloxane, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Isopropyl Palmitate, Polyquaternium-37, Propylene Glycol Dicaprylate Dicaprate, PPG-1 Trideceth-6, Propylene Glycol, Purified Water, Triethanolamine

Section 51945-4

BOA

VIDA

Antifungal

Cream

Relieves itching and

burning discomfort associated

with most jock itch, ringworm,

and athlete's foot

4 oz. (113g)

Section 55105-1

Purpose

Skin protectant

Section 55106-9

Active Ingredients

Miconazole Nitrate 2%


Structured Label Content

Indications and Usage (34067-9)

Uses

Treats most jock itch, ringworm and athlete's foot

Dosage and Administration (34068-7)

Directions

Cleanse the affected area and dry thoroughly.

Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician. Supervise children in the use of this product.

Athlete's foot

Pay special attention to the spaces between toes

wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Athlete's foot and ringworm

use daily for 4 weeks

Jock Itch

use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp or nails.



Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 44425-7 (44425-7)

Other Information

Store at 59-86 F (15-30 C)

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)

If irritation occurs or if there is no improvement withing 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch, discontinue use and consult a doctor.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age for diaper rash.

Section 51727-6 (51727-6)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cyclopentasiloxane, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Isopropyl Palmitate, Polyquaternium-37, Propylene Glycol Dicaprylate Dicaprate, PPG-1 Trideceth-6, Propylene Glycol, Purified Water, Triethanolamine

Section 51945-4 (51945-4)

BOA

VIDA

Antifungal

Cream

Relieves itching and

burning discomfort associated

with most jock itch, ringworm,

and athlete's foot

4 oz. (113g)

Section 55105-1 (55105-1)

Purpose

Skin protectant

Section 55106-9 (55106-9)

Active Ingredients

Miconazole Nitrate 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)