Label: CLOTRIMAZOIL ANTIFUNGAL- clotrimazole solution
- NDC Code(s): 68927-3490-1
- Packager: Pedifix, Inc.
- 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 April 23, 2021
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- ClotrimazOil Antifungal Solution
- Active Ingredient
For external use only
Stop Use and Ask Doctor If:
- irritation occurs
- there is no improvement within 4 weeks (2weeks for jock itch).
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.
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 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.
- Intended for use by normally healthy adults only.
- Persons under 12 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
Applyto 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 until satisfactory results are obtained.
- You may report serious side effects to the phone number provided under Questions? Comments? on side panel.
- Questions? Comments?
ClotrimazOil Antifungal Solution CLOTRIMAZOLE 1%
Kills More Types of Fungus
No Touch, No Mess Brush-on Applicator
Manufactured in the USA for: PediFix, Inc. 301 Fields Lane Brewster, NY 10509 USA
Item #3490 REV321 ©2021 PediFix, Inc.
PediFix, ClotrimaZoil and the No Sore Feet Symbol are trademarks of PediFix, Inc.
- PRINCIPAL DISPLAY PANEL
- ClotrimazOil Antifungal Solution .5oz/15ml (68927-3490-1)
INGREDIENTS AND APPEARANCE
Product 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) Establishment Name Address ID/FEI Business Operations PURE SOURCE 080354456 manufacture(68927-3490) Establishment Name Address ID/FEI Business Operations PEDIFIX, INC. 122271935 label(68927-3490)