MICONAZOLE NITRATE cream

MICONAZOLE NITRATE by

Drug Labeling and Warnings

MICONAZOLE NITRATE by is a Otc medication manufactured, distributed, or labeled by Delsam Pharma Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole Nitrate USP 2%

Purpose

Antifungal

Uses

effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
for effective relief of itching, scaling, cracking, burning and discomfort that can accompany these conditions.

Warnings

For external use only

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

When using this product avoid contact with 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

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 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

Inactive ingredients

Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Micro crystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water

Other information

Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal store at temperature not exceeding 30°C (86°F). Do not freeze. see carton or tube crimp for lot number and expiration date

Questions or comments?

1-866-826-‬1306 between 9 am and 4 pm EST, Monday - Friday.

SPL UNCLASSIFIED SECTION

CURES MOST ATHLETE'S FOOT

Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

Compared to the active ingredient in Micatin

Distributed by.

Delsam Pharma Llc

Bronx, Newyork, 10467

Packaging

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-104
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CHLOROCRESOL (UNII: 36W53O7109)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (White to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-104-30	1 in 1 CARTON	09/25/2018
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 final	part333C	09/25/2018

Labeler - Delsam Pharma Llc (081369679)