![CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]](https://medic.hrt.org//dailymed/images/fd79346a-fba3-49ec-9cd3-5c00bedb4acb/OuterLabel.jpg)
| NDC | 68927-3490-1 |
| Set ID | fd79346a-fba3-49ec-9cd3-5c00bedb4acb |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Pedifix, Inc. |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | PART333C |
- ClotrimazOil Antifungal Solution
- Active Ingredient
- Purpose
- Uses:
- Warnings:
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Inactive Ingredients:
Aqua (Deionized Water), BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycine Soja (Soybean) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Tocopheryl Acetate (Vitamin-E), Urea.
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Directions:
Read all package directions and warnings before using.
- Use only as directed.
- Clean the affected area with soap and warm water and dry thoroughly.
- Apply a thin layer of CLORTIMAZOIL over the affected area twice daily (morning and night) or as directed by a doctor.
- This product is not effective on the scalp or nails.
- Avoid applying to severely cracked or irritated areas.
- For athlete’s foot: pay special attention to spaces between 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.
- Supervise children in the use of this product.
- Supervise children in the use of this product.
- Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
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Other Information
Apply CLOTRIMAZOIL to skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use CLOTRIMAZOIL until satisfactory results are obtained.
- You may report serious side effects to the phone number provided under Questions? Comments? on side panel.
- Questions? Comments?
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ClotrimazOil Antifungal Solution CLOTRIMAZOLE 1%
DOCTOR RECOMMENDED
Broad Spectrum Antifungal Kills 6 Types of Fungus
Highly effective on infected surfaces, wherever reachable with the brush-on applicator.
Manufactured in the USA for: PediFix, Inc. 281 Fields Lane Brewster, NY 10509 USA
Lot #:
Exp. Date:
Item #3490 REV513 ©2013 PediFix, Inc.
PediFix and ClotrimazOil are trademarks of PediFix, Inc.
- PRINCIPAL DISPLAY PANEL
- ClotrimazOil Antifungal Solution .5oz/15ml (68927-3490-1)
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOIL ANTIFUNGAL
clotrimazole solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68927-3490 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SAFFLOWER OIL (UNII: 65UEH262IS) EMU OIL (UNII: 344821WD61) EUCALYPTUS OIL (UNII: 2R04ONI662) SOYBEAN OIL (UNII: 241ATL177A) LAVENDER OIL (UNII: ZBP1YXW0H8) PEPPERMINT OIL (UNII: AV092KU4JH) OLIVE OIL (UNII: 6UYK2W1W1E) ALMOND OIL (UNII: 66YXD4DKO9) JOJOBA OIL (UNII: 724GKU717M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) UREA (UNII: 8W8T17847W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68927-3490-1 1 in 1 CARTON 02/07/2017 1 15 mL in 1 BOTTLE; 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 06/19/2013 Labeler - Pedifix, Inc. (122271935)
