SALLY HANSEN NO MORE FUNGUS- undecylenic acid liquid 
Coty US LLC

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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Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

cures most ringworm (tinea corporis) and athlete's foot (tinea pedis).

Soothes:

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

Avoid contact with eyes.

Stop use and ask a doctor if:

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use daily for 4 weeks. This product is not effective on the scalp or nails.

For athlete's foot:

Other Information

Inactive ingredients

proplylene glycol dicaprylate/dicaprate, parfum/fragrance, limonene, linalool

Questions or comments?

To report a serious adverse event and for informaiton or comments on this product call us at 1-800-953-5080

9:00AM-5:00PM EST or visit www.sallyhansen.com

Outer Package

Primary

SALLY HANSEN  NO MORE FUNGUS
undecylenic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-151
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 0.23125 g  in 39.01 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66184-151-02 1 in 1 BOX
1 NDC:66184-151-01 39.0 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 01/01/2012
Labeler - Coty US LLC (789573201)
Establishment
Name Address ID/FEI Business Operations
Kolmar Laboratories Inc. 001535103 manufacture(66184-151)

Revised: 2/2013
Document Id: 193413f0-f2ad-465e-95d4-590be44b96f3
Set id: 9f12bfcb-c0f5-4113-996c-917976c01349
Version: 1
Effective Time: 20130213
 
Coty US LLC