Label: SALLY HANSEN NO MORE FUNGUS- undecylenic acid liquid
- NDC Code(s): 66184-151-01, 66184-151-02
- Packager: Coty US LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 13, 2013
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- Active Ingredient
Undecylenic Acid 25%Close
cures most ringworm (tinea corporis) and athlete's foot (tinea pedis).
- itchy, scaling skin between the toes
- itching, burning feet
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.Close
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, linaloolClose
- Questions or comments?
- 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 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)