Label: FUNGAZOIL ADVANCED- clotrimazole 1% liquid
- NDC Code(s): 68927-3492-1
- Packager: Pedifix
- 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 June 12, 2014
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For external use only
Ask a doctor before use on children under 2 years of age
When using this product avoid contact with eyes
Stop use and as doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)
If swallowed, get medical help or contact a Poison control center immediately.
- Active Ingredient
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.
- KEEP OUT OF REACH OF CHILDREN
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.
• Super vise children in the use of this product.
• Intended for use by normally healthy adults only.
• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
Apply 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 until satisfactory results are obtained.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
clotrimazole 1% liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68927-3492 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 .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SAFFLOWER OIL (UNII: 65UEH262IS) EMU OIL (UNII: 344821WD61) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) SOYBEAN OIL (UNII: 241ATL177A) LAVENDER OIL (UNII: ZBP1YXW0H8) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) OLIVE OIL (UNII: 6UYK2W1W1E) ALMOND OIL (UNII: 66YXD4DKO9) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) JOJOBA OIL (UNII: 724GKU717M) UREA (UNII: 8W8T17847W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68927-3492-1 15 mL in 1 BOTTLE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 06/15/2014 Labeler - Pedifix (122271935) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture(68927-3492)