Label: MICONAZOLE NITRATE ointment
- NDC Code(s): 84387-003-01
- Packager: ALLIED TRADE LINK LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2024
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- Uses
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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
- Stop use and ask a doctor if
- Keep out of reach of children
- Other Information
- Inactive Ingredients
- Active Ingrediant
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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 feetClean 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
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate ointmentProduct 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)