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.

Active Ingredient

Active Ingredients

Miconazole Nitrate 2%

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active Ingredients

Miconazole Nitrate 2%

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.



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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)