Label: TOLCYLEN ANTIFUNGAL SOLUTION- tolnaftate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70945-100-75 - Packager: Marlinz Pharma, 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.
Drug Label Information
Updated February 1, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Warnings
- Uses
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Warnings
Do not use on children under 2 years of age ■ For external use only ■ Avoid contact with the eyes. If eye contact occurs, wash thoroughly with
water ■ Stop use and consult a physician if irritation occurs or if there is no improvement within four (4) weeks ■ Keep out of reach of children ■ If swallowed,
get medical help or contact a poison control center right away ■ If pregnant or breast-feeding, ask a health-care professional before use. -
Directions
Wash the affected area with soap and water.
■ Dry thoroughly, then apply a thin layer over the affected area.
■ Use twice daily (morning and night) or as directed by a physician.
■ Pay special attention to the spaces between the toes and the areas around the edges and under the front of the nails.
■ Wear well-fitted ventilated shoes and change socks at least once daily.
■ Use daily for four (4) weeks. If condition persists longer, consult a physician.
■ Wash hands after each use. Store and use at room temperature. - Inactive Ingredeints
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOLCYLEN ANTIFUNGAL SOLUTION
tolnaftate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70945-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 mg in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LACTIC ACID (UNII: 33X04XA5AT) ETHYL ACETATE (UNII: 76845O8NMZ) UREA (UNII: 8W8T17847W) UNDECYLENIC ACID (UNII: K3D86KJ24N) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) JOJOBA OIL (UNII: 724GKU717M) Product Characteristics Color yellow (Clear Fluid) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70945-100-75 1 in 1 CARTON 12/16/2016 1 7.5 mL in 1 TUBE, WITH APPLICATOR; 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 12/16/2016 Labeler - Marlinz Pharma, LLC (080251509)