FDA Label for Sanafitil
View Indications, Usage & Precautions
Sanafitil Product Label
The following document was submitted to the FDA by the labeler of this product Zurich Medical Labs, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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.
Otc - When Using
- When using this product avoid contact with eyes and mucous membrane.
Otc - Do Not Use
- Do not use on children under 2 years of age except under the advice and supervision of a doctor.
- Not for diaper rash
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
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)
* Please review the disclaimer below.
