Label: DERMAN ANTIFUNGAL- zinc undecylenate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69772-125-01, 69772-125-02, 69772-125-03 - Packager: Teresa Cecena DBA Genesis
- 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 May 20, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USER SAFETY WARNINGS
- WARNINGS
- DO NOT USE
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DOSAGE & ADMINISTRATION
Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician.
This product is not effective on the scalp or nails.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician.
This product is not effective on the scalp or nails
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INGREDIENTS AND APPEARANCE
DERMAN ANTIFUNGAL
zinc undecylenate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69772-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 5 g in 100 g ZINC UNDECYLENATE (UNII: 388VZ25DUR) (UNDECYLENIC ACID - UNII:K3D86KJ24N) ZINC UNDECYLENATE 18 g in 100 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ZINC STEARATE (UNII: H92E6QA4FV) SODIUM BISULFITE (UNII: TZX5469Z6I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69772-125-02 1 in 1 CARTON 05/14/2015 1 NDC:69772-125-01 25 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69772-125-03 1 in 1 CARTON 05/20/2015 2 50 g in 1 TUBE; 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 05/14/2015 Labeler - Teresa Cecena DBA Genesis (078760958) Registrant - Teresa Cecena (078760958) Establishment Name Address ID/FEI Business Operations Teresa Cecena DBA Genesis 078760958 relabel(69772-125) Establishment Name Address ID/FEI Business Operations COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I.DE C.V. 815039995 manufacture(69772-125)
