Drug Labeling and Warnings

Drug Details

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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:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort
  • itchy, scaling skin between the toes
  • itching, burning feet

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:

  • irritation occurs
  • there is not improvement within 4 weeks.

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.

  • wash the affected area and dry thoroughly
  • apply a thin layer 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

For athlete's foot:

  • pay special attention to spaces between the toes
  • wear well-fitting, veniltated shoes
  • change shoes and socks at least once daily

Other Information

  • do not use if the printed seal is broken or missing prior to opening
  • keep away from direct sunlight

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 66184-151
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID0.23125 g  in 39.01 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66184-151-021 in 1 BOX01/01/2012
1NDC: 66184-151-0139 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2012
Labeler - Coty US LLC (039056361)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Laboratories Inc.001535103manufacture(66184-151)

Revised: 2/2019
 
Coty US LLC


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