MICONAZOLE NITRATE cream

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by STRATEGIC SOURCING SERVICES LLC, Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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, burning and discomfort that can accompany these conditions

Warnings

For external use only

Do not useon children less than 2 years of age unless directed by a doctor

When using this productavoid contact with the eyes

Stop use and ask a doctor if

• irritation occurs
• condition persists
• there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 the 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
• not effective on the scalp or nails

Other information

• TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
• to open: unscrew cap, use the pointed end on cap to puncture seal
• store at 20° to 25°C (68° to 77°F)
• see carton flap or tube crimp for lot number and expiration date

Inactive ingredients

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water

Questions?

call 833-358-6431

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Distributed by:McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Foster & Thrive™

Antifungal Cream

Miconazole Nitrate Cream USP, 2%
ANTIFUNGAL

NET WT 1 OZ (30 g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-7 LINOLEOYL GLYCERIDES (UNII: 993L8OB0ER)
GLYCOL STEARATE (UNII: 0324G66D0E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1000-1	1 in 1 CARTON	07/14/2023
1		30 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	07/14/2023

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(70677-1000)