Label: LOTRIMIN ANTIFUNGAL- miconazole nitrate powder
- NDC Code(s): 11523-0919-1
- Packager: MSD Consumer care, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Miconazole nitrate 2%Close
- Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
- relieves itching, cracking, burning and scaling
For external use only
Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- wash affected area and dry thoroughly
- sprinkle a thin layer over affected area twice daily (morning and night)
- 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, ask a doctor
- this product is not effective on the scalp or nails
- Other information
store between 20° to 25°C (68° to 77°F)Close
- Inactive ingredients
benzethonium chloride, corn starch, kaolin, sodium bicarbonate, starch/acrylates/acrylamide copolymer, zinc oxideClose
- SPL UNCLASSIFIED SECTION
© Copyright & Distributed by MSD Consumer Care, Inc.,Close
PO Box 377, Memphis, TN 38151 USA, a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ USA.
- PRINCIPAL DISPLAY PANEL - 90g Can Label
- Absorbs Moisture
Burning & Scaling
NET WT 90g (3 OZ)
- INGREDIENTS AND APPEARANCE
miconazole nitrate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0919 Route of Administration TOPICAL DEA Schedule 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 benzethonium chloride (UNII: PH41D05744) starch, corn (UNII: O8232NY3SJ) kaolin (UNII: 24H4NWX5CO) sodium bicarbonate (UNII: 8MDF5V39QO) zinc oxide (UNII: SOI2LOH54Z) 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:11523-0919-1 90 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 09/01/1993 Labeler - MSD Consumer care, Inc. (968091715)