- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
-
Warning
- For external use only.
- Do not use on children under 2 years of age except under the advice and supervision of a doctor.
- Not for diaper rash
-
Directions
- Clean affected area and dry thoroughly.
- Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor.
- For athlete's foot pay special attention to the space between the toes. Wear well fitting, ventilated shoes and change shoes & socks at least once a day.
- For athlete's foot and ringworm, use daily for 4 weeks
- For jock itch use daily for 2 weeks.
- Supervise Children in use of this product.
- Product not effective in the scalp or nails.
- Other Information
- Other ingredients
- PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton
-
INGREDIENTS AND APPEARANCE
SANAFITIL
undecylenic acid ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11096-190 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid 100 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) BENZOCAINE (UNII: U3RSY48JW5) PARAFFIN (UNII: I9O0E3H2ZE) HEXYL SALICYLATE (UNII: 8F78EY72YL) BENZOIC ACID (UNII: 8SKN0B0MIM) BORIC ACID (UNII: R57ZHV85D4) METHYL SALICYLATE (UNII: LAV5U5022Y) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) MENTHOL (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11096-190-01 1 in 1 CARTON 1 28.35 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/24/1966 Labeler - Tarmac Products, Inc (059890491) Establishment Name Address ID/FEI Business Operations Tarmac Products, Inc 059890491 MANUFACTURE(11096-190)