ANTI-FUNGAL PEN CVS- undecylenic acid liquid 
CVS

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.

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Drug Facts

Active ingredient                          Purpose


Undecylenic Acid 25%..................Anti-fungal

Uses

For the cure of most • ringworm (tinea corporis) • athlete’s foot (tinea pedis) For the relief of: • itching • scaling • cracking
•burning• redness • soreness • irritation and discomforts which may accompany these conditions

Warnings
For external use only.
Ask a doctor before use on children under 2 years of age
When using this product avoid contact with eyes
Stop use and ask doctor if • irritation occurs • there is no improvement within 4 weeks

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

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 ingredients : Isopropyl Palmitate, Propylparaben

Other Information Store at 15°-30°C (59°-86°F) • Keep cap on pen when not in use

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ANTI-FUNGAL PEN  CVS
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-835
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) Undecylenic Acid25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-835-011 in 1 CARTON09/15/2016
11.7 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/15/2016
Labeler - CVS (062312574)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(59779-835) , label(59779-835)

Revised: 12/2017
Document Id: c3e5ee58-0453-4842-a372-ae95d4823618
Set id: 2da74531-118f-4817-8871-50980ade6e5d
Version: 2
Effective Time: 20171212
 
CVS