Label: DERMAN ANTIFUNGAL- undecylenic acid spray
- NDC Code(s): 54312-325-05
- Packager: Compania Internacional de Comercio, S.A.P.I de C.V.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 28, 2023
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
Wash the affected area and dry thoroughly. Apply a few drops of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp and nails.
- Inactive ingredients
- Package Labeling:
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INGREDIENTS AND APPEARANCE
DERMAN ANTIFUNGAL
undecylenic acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54312-325 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54312-325-05 1 in 1 PACKAGE 10/21/2013 1 35 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 Drug M005 10/21/2013 Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213) Establishment Name Address ID/FEI Business Operations Compania Internacional de Comercio, S.A.P.I de C.V. 822165213 manufacture(54312-325)