Label: ANTI-FUNGAL PEN CVS- undecylenic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-835-01 - Packager: CVS
- 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 December 12, 2017
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• read all warnings and directions • use only as directed • clean the affected area with soap and water and dry
thoroughly • remove cap from pen • twist the base of the pen, with brush pointing downward, until product dispenses • apply a
thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor • for athlete's foot: pay
special attention to spaces between the 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. if condition persists longer, consult a doctor • intended for use by normally
healthy adults only • persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a
doctor • supervise children in the use of this product • this product is not effective on the scalp or nails - INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-FUNGAL PEN CVS
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-835 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Undecylenic Acid (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) Undecylenic Acid 25 g in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-835-01 1 in 1 CARTON 09/15/2016 1 1.7 mL in 1 CONTAINER; 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 09/15/2016 Labeler - CVS (062312574) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(59779-835) , label(59779-835)