SALLY HANSEN NO MORE FUNGUS- undecylenic acid liquid

Sally Hansen by

Drug Labeling and Warnings

Sally Hansen by is a Otc medication manufactured, distributed, or labeled by Coty US LLC, Kolmar Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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	01/01/2012
1	NDC: 66184-151-01	39 mL in 1 BOTTLE, DROPPER; 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	01/01/2012

Labeler - Coty US LLC (039056361)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Laboratories Inc.		001535103	manufacture(66184-151)