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Sanafitil

ZURICH MEDICAL LABS, LLC

Sanafitil Solución


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Undecylenic Acid 10%

Purpose

Antifungal

Sanafitil Uses

  • Cures most athlete's foot, jock itch & ringworm
  • Relieves itching, burning, cracking, and discomfort which accompany these conditions

Warning

  • For external use only.
  • Not for diaper rash
  • 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.

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 & 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

Other ingredients

isopropyl alcohol, purified water, benzocaine, salicylic acid, benzoic acid, methyl salicylate, boric acid, methyl paraben, mentol, propyl paraben, FD&C red #22.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SANAFITIL®

ANTIFUNGAL
SOLUTION

• Relieves itching, burning, cracking, and
discomfort

1 OZ (30mL)

Sanafitil

Sanafitil

Undecylenic Acid LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61357-146
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
BENZOCAINE
HEXYL SALICYLATE
BENZOIC ACID
BORIC ACID
methyl salicylate
METHYLPARABEN
PROPYLPARABEN
MENTHOL
ISOPROPYL ALCOHOL
FD&C RED NO. 40
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:61357-146-01 1 in 1 CARTON

Marketing Information

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


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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