ANTI-FUNGAL- miconazole nitrate cream

Anti-Fungal by

Drug Labeling and Warnings

Anti-Fungal by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Miconazole Nitrate 2%

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

• cures most athlete's foot, jock itch, and ringworm.
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

WARNINGS

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

WHEN USING

When using this product avoid contact with eyes.

STOP USE

Stop using this product and ask a doctor

• irritation occurs
• there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
• do not use for diaper rash

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

• wash affected area and dry thoroughly

• Apply a thin layer 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 a day

• for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks

• if conditions persist longer, ask a doctor

• this product is not effective on the scalp or nails.

SPL UNCLASSIFIED SECTION

Other information

• Store between 20ºC to 25º C (68ºF to 77º F)
• Lot No. & Exp. Date: see crimp of tube.

INACTIVE INGREDIENT

Inactive Ingredients

Purified water, cetostearyl alcohol, cetomacrogol-1000, mineral oil, petrolatum, propyleneglycol, sodium phosphate, chlorocresol.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Anti-Fungal Cream

NET WT 0.5 OZ (14 g)

INGREDIENTS AND APPEARANCE

ANTI-FUNGAL 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CHLOROCRESOL (UNII: 36W53O7109)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-061-01	1 in 1 BOX	12/09/2020
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/09/2020

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52000-061)