Label: SMOOTH GATOR FUNGUS ELIMINATOR- clotrimazole liquid
- NDC Code(s): 70673-747-01
- Packager: Smooth Gator, 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 February 7, 2017
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- DRUG FACTS
- Active ingredients:
- For external use only.
Stop use and ask doctor if
Irritation occurs or there is no improvement within 4 weeks (2 weeks for jock itch).
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.
• 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 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
- Other information:
BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus(Eucalyptus) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).
- Package Labeling:
INGREDIENTS AND APPEARANCE
SMOOTH GATOR FUNGUS ELIMINATOR
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70673-747 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 BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SAFFLOWER (UNII: 4VBL71TY4Y) EMU OIL (UNII: 344821WD61) EUCALYPTUS OIL (UNII: 2R04ONI662) SOYBEAN OIL (UNII: 241ATL177A) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) LAVENDER OIL (UNII: ZBP1YXW0H8) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT) ALMOND OIL (UNII: 66YXD4DKO9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70673-747-01 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/29/2016 Labeler - Smooth Gator, LLC (029819479)