SANAFITIL- undecylenic acid ointment 
Tarmac Products, Inc

----------

SANAFITIL®
OINTMENT

Drug Facts

Active Ingredients

Undecylenic Acid 10%

Purpose

Antifungal

Uses

  • For the treatment of most athlete's foot, jock itch & ringworm
  • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warning

  • For external use only.

  • When using this product avoid contact with eyes and mucous membrane.

  • Do not use on children under 2 years of age except under the advice and supervision of a doctor.
  • Not for diaper rash

Stop use and ask a doctor if

  • Irritation occurs
  • There is no improvement within 4 weeks of treatment for athlete's foot and ringworm and 2 weeks of treatment for jock itch discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion seek professional assistance or contact a poison control center right away.

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

Store at 59° - 86° F (15°- 30°C)

Other ingredients

petrolatum white, benzocaine, paraffin wax, salicylic acid, benzoic acid, boric acid, methyl salicylate, methyl paraben, propyl paraben, menthol crystals

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

SANAFITIL®

(Undecylenic Acid 10%)

ANTIFUNGAL

OINTMENT

1 OZ. (28.35g)

Principal Display Panel - 28.35 g Tube Carton
SANAFITIL 
undecylenic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11096-190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11096-190-011 in 1 CARTON08/24/196604/01/2020
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00508/24/196604/01/2020
Labeler - Tarmac Products, Inc (059890491)
Establishment
NameAddressID/FEIBusiness Operations
Tarmac Products, Inc059890491MANUFACTURE(11096-190)

Revised: 2/2024
Document Id: d721a51d-9e59-44dc-a4be-ca6d5d9a537a
Set id: 43089f7f-486f-4dd0-9a77-e0e0441c1e9e
Version: 2
Effective Time: 20240216
 
Tarmac Products, Inc