FDA Label for Nailene Antifungal Treatment
View Indications, Usage & Precautions
Nailene Antifungal Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Pacific World Corporation. 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
Imported & Distributed by:
UK/R.-U.: Pacific World Ltd.,
Stoke-on-Trent, Staffordshire. ST4 2 PJ
Australia: Creative Brands PTY LTD
30 Bando Road, Springvale, VIC 3171
South Africa: Indigo Cosmetics, Cape Town, 7460
New Zealand: BDM Grange, Auckland
Active Ingredient
Tolnaftate 1%
Purpose
Antifungal
Uses
- Cures most fungal skin infections, including athlete's foot (tinea pedis) and ringworm (tinea corporis)
- Effectively relieves itching, burning, cracking and scaling accompanying such conditions
Warnings
For external use only.
Do Not Use
- near the mouth or eyes
- with known sensitivities to any listed ingredients
- on children under 2 years of age unless directed by a doctor
Otc - When Using
When using this product avoid eye contact. If accidental eye contact occurs, rinse thoroughly with water for 10-15 minutes.
Otc - Stop Use
Stop use and ask a doctor if rash or irritation occurs, or if no improvement is seen after four weeks.
Otc - Pregnancy Or Breast Feeding
If pregnant/breast-feeding, consult a health professional before using.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- Clean affected area with soap and warm water and dry thoroughly
- Apply a thin layer two times a day (mornings and evenings) to affected area especially the space between and around toes
- For athlete's foot, use daily for four weeks or as directed by a physician
- Allow solution to soak into skin or rub in to dry more quickly before putting on socks
- This product is not effective on scalp or nails.
- Following a proper foot hygiene regimen along with wearing well fitting, ventilated shoes and clean socks that are changed at least daily is helpful in preventing future infections
Other Information
You may report questions or adverse reaction from using this product to 1(541)-476-3178, 8 am to 5 pm (M–F), PST.
Inactive Ingredients
Water (Aqua), Caprylic/Capric Triglycerides, Isopropyl Palmitate, Polyquaternium 37, Propylene Glycol, Dicaprylate Dicaprate, PPG-1 Trideceth-6, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Phemerol Chloride, Cetrimonium Chloride, Allantoin, Didecyldimonium Chloride, Quaternium-15.
Principal Display Panel - 18 Ml Bottle Carton
new
61100
nailene®
DOCTOR
FORMULATED
MAXIMUM STRENGTH
ANTIFUNGAL
TREATMENT
Powered by
MYCOCIDE®
For finger and
toe areas
No need to remove
nail polish or acrylics
INCLUDES:
2 Extra-Coarse Nail Grinders
NET WT .6 FL OZ (18 mL) Antifungal Liquid
* Please review the disclaimer below.