Nailene®

Nailene®
SPL v3
SPL
SPL Set ID ae22a4f1-77bd-4b37-bf3c-24f402e15bf0
Route
TOPICAL
Published
Effective Date 2014-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Isopropyl Palmitate Polyquaternium-37 (3000 Mpa.s) Propylene Glycol Dicaprylate/dicaprate Cocamidopropyl Betaine Benzethonium Chloride Cocamidopropylamine Oxide Allantoin Ppg-1 Trideceth-6 Cetrimonium Chloride Didecyldimonium Chloride Quaternium-15 Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-04-24

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if rash or irritation occurs, or if no improvement is seen after four weeks.

Section 50567-7

When using this product avoid eye contact. If accidental eye contact occurs, rinse thoroughly with water for 10-15 minutes.

Section 53414-9

If pregnant/breast-feeding, consult a health professional before using.

Warnings

For external use only.

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
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
Active Ingredient

Tolnaftate 1%

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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash or irritation occurs, or if no improvement is seen after four weeks.

Section 50567-7 (50567-7)

When using this product avoid eye contact. If accidental eye contact occurs, rinse thoroughly with water for 10-15 minutes.

Section 53414-9 (53414-9)

If pregnant/breast-feeding, consult a health professional before using.

Purpose

Antifungal

Warnings

For external use only.

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
Do Not Use (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
Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (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 (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 (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


Advanced Ingredient Data


Raw Label Data

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