Nailene Antifungal Treatment
FDA Label NDC 60193-102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pacific World Corporation for the product Nailene Antifungal Treatment (NDC 60193-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Principal Display Panel (18 mL Bottle Carton)

Principal Display Panel (18 mL Bottle Carton)

* Please review the disclaimer below.