2% Miconazole Nitrate Cream, Usp

2% Miconazole Nitrate Cream, Usp
SPL v3
SPL
SPL Set ID b564f971-2a9b-a605-e053-2995a90aee69
Route
TOPICAL
Published
Effective Date 2021-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Edetate Disodium Cetostearyl Alcohol Light Mineral Oil Chlorocresol Propylene Glycol Water White Petrolatum Sodium Phosphate Dibasic Dihydrate Sodium Phosphate, Monobasic, Dihydrate Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

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

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.
Do Not Use
  • On children under 2 years of age unless directed by a doctor
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

Active Ingredient

Miconazole Nitrate 2%



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.

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.

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

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

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

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

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

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


Structured Label Content

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.
Purpose

Antifungal

Warnings

For external use only

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.
Do Not Use (Do not use)
  • On children under 2 years of age unless directed by a doctor
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

Active Ingredient (Active ingredient)

Miconazole Nitrate 2%



Other Information (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 (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.

When Using This Product (When using this product)
  • Avoid contact with the eyes
Stop Use and Ask A Doctor If (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 (Keep out of reach of children)

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

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

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

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

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

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

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


Advanced Ingredient Data


Raw Label Data

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