MICONAZOLE NITRATE ointment

MICONAZOLE NITRATE by

Drug Labeling and Warnings

MICONAZOLE NITRATE by is a Otc medication manufactured, distributed, or labeled by ALLIED TRADE LINK LLC, GOPALDAS VISRAM AND COMPANY LMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) 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 For diaper rash.
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 Center right away.

Do not use

Do not use On children under 2 years of age unless directed by a
doctor For diaper rash.

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 Center right away.

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 See
crimp of tube or carton for Lot Number and Expiry Date Preserve in
well-closed containers, and store controlled room temperature

Inactive Ingredients

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

Active Ingrediant

Miconazole Nitrate 2%

WARNINGS FOR EXTERNAL USE ONLY

Miconazole Nitrate 2%

For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
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 Center right away.

DIRECTIONS AND USES

Uses
For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort
and chafing associated with jock itch or itching, burning feet

Clean the affected area and dry thoroughly Apply a thin layer of the cream 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 the scalp or nails

PURPOSDE

Miconazole Nitrate 2% ........................................................................................................................................................................................................................................................................... Antifungal

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84387-003
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)
CHLOROCRESOL (UNII: 36W53O7109)
CETEARETH-12 (UNII: 7V4MR24V5P)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84387-003-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	10/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/25/2024

Labeler - ALLIED TRADE LINK LLC (029033682)

Registrant - ALLIED TRADE LINK LLC (029033682)

Establishment
Name	Address	ID/FEI	Business Operations
GOPALDAS VISRAM AND COMPANY LMITED		858030888	manufacture(84387-003)