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Sanafitil

ZURICH MEDICAL LABS, LLC

SanafitilUngüento


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Undecylenic Acid 10%

Purpose

Antifungal

Sanafitil 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)

Sanafitil

Sanafitil

Undecylenic Acid OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61357-149
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UNDECYLENIC ACID 100 mg

Inactive Ingredients

Ingredient Name Strength
petrolatum
BENZOCAINE
PARAFFIN
HEXYL SALICYLATE
BENZOIC ACID
BORIC ACID
methyl salicylate
METHYLPARABEN
PROPYLPARABEN
MENTHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.35 in 1 TUBE
2 NDC:61357-149-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 1966-08-24


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Be sure to consult your doctor before taking any medication!
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