Label: LOTRIMIN ANTIFUNGAL- miconazole nitrate powder
- NDC Code(s): 11523-0919-1
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated September 14, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
Do not use on children under 2 years of age unless directed by a doctor.
Stop use and ask a doctor if
- irritation occurs
- if there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
- 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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 90g Can Label
INGREDIENTS AND APPEARANCE
miconazole nitrate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0919 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 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; Type 0: Not a Combination Product 09/01/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/01/1993 Labeler - Bayer HealthCare LLC. (112117283)