BUDPAK ANTIFUNGAL MICONAZOLE NITRATE- miconazole nitrate cream

Budpak Antifungal Miconazole Nitrate by

Drug Labeling and Warnings

Budpak Antifungal Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Budpak Inc. , Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Miconazole Nitrate 2.0%

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 15ºC to 30º C (59ºF to 86º F)
• Lot No. & Exp. Date: see crimp of tube.

INACTIVE INGREDIENT

Inactive Ingredients

Benzoic Acid, Butylated Hydroxy Anisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Antifungal Cream

Miconazole Nitrate 2%

Antifungal for Athlete’s Foot and Jock Itch

NET WT 0.5 OZ (14 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK ANTIFUNGAL MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-023
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-5 OLEATE (UNII: 0240V77G50)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-023-01	1 in 1 BOX
1	NDC: 27293-023-14	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/29/2013

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-023)