OTC Medication Information: Antifungal

ANTIFUNGAL- miconazole nitrate cream
Preferred Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Miconazole nitrate, USP 2%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most athlete’s foot, jock itch, and ringworm
for effective relief of itching, scaling, cracking, burning, and discomfort

Warnings

For external use only

Do not use

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

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks (for athlete’s foot and ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children.

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

Directions

wash the affected area and dry thoroughly
apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor
supervise children in the use of this product
for athlete’s foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and 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 lasts longer, contact a doctor
this product is not effective on the scalp or nails

Other information

store at controlled room temperature 59°-86°F (15°-30°C).
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Principal Display Panel

Actavis
NDC 68788-7374-2
Compare to the active ingredient in Micatin® Antifungal Cream*

Antifungal Cream
Miconazole Nitrate Cream, USP 2%
Soothes Itching, Scaling, Cracking, and Burning

Cures Most Athlete’s Foot, Jock Itch & Ringworm

Net wt. 0.5 oz (14g)

Relabeled By: Preferred Pharmaceuticals Inc.

Miconazole Nitrate 2% Cream
(click image for full-size original)
ANTIFUNGAL
miconazole nitrate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7374(NDC:0472-0735)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
MINERAL OIL
PEGOXOL 7 STEARATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7374-2 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (68788-7374-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 08/25/2016
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-7374)

Revised: 07/2020 Preferred Pharmaceuticals Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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