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Nailene Antifungal Treatment

Medically reviewed on October 17, 2017.

Dosage form: liquid
Ingredients: TOLNAFTATE 10mg in 1mL
Labeler: Pacific World Corporation
NDC Code: 60193-102

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Nailene® Antifungal Treatment

Drug Facts

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

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

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

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

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.

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

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

NAILENE ANTIFUNGAL TREATMENT 
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60193-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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) 
Packaging
#Item CodePackage Description
1NDC:60193-102-021 BOTTLE, WITH APPLICATOR in 1 CARTON
118 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C04/24/2013
Labeler - Pacific World Corporation (089693097)

 
Pacific World Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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