ANTIFUNGAL CREAM- antifungal cream

Antifungal Cream by

Drug Labeling and Warnings

Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, Gopaldas Visram & Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), Ringworm (tinea corporis).
• For the treatment of superficial skin infections caused by yeast (Candida Albicans)
• Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet.

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 2 weeks when used for the treatment of jock itch
• there is no improvement within 4 weeks when used for athlete's foot and ringworm

Keep out of reach of children

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

Directions

• Clean 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 persists longer, consult a doctor.
• This product is not effective on scalp or nails.

Other information

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
• Store at controlled room temperature.
• Preserve in tight container.
• See crimp of tube or carton for Lot Number and expiry date.

Inactive ingredients

Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether 20, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum.

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram and Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai - 400710 Mfg. Lic. No.: KD/739

For BluePoint Laboratories

2% Miconazole Nitrate Cream, USP Carton 1oz (28.4g)

2% Miconazole Nitrate Cream, USP Tube 1oz (28.4g)

2% Miconazole Nitrate Cream, USP Carton 0.5oz (14.2g)

2% Miconazole Nitrate Cream, USP Tube 0.5oz (14.2g)

2% Miconazole Nitrate Cream, USP Carton 1.5oz (42.5g)

2% Miconazole Nitrate Cream, USP Tube 1.5oz (42.5g)

INGREDIENTS AND APPEARANCE

ANTIFUNGAL CREAM 
antifungal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-481
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CHLOROCRESOL (UNII: 36W53O7109)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-481-45	1 in 1 CARTON	12/01/2020
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68001-481-47	1 in 1 CARTON	12/01/2020
2		42.5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68001-481-48	1 in 1 CARTON	12/01/2020
3		14.2 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 Drug	M005	12/01/2020

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co., Ltd		858030888	manufacture(68001-481)