NAILENE ANTIFUNGAL TREATMENT- tolnaftate liquid 
Pacific World Corporation

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.

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Nailene® Antifungal Treatment

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

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

Principal Display Panel - 18 mL Bottle Carton
NAILENE ANTIFUNGAL TREATMENT 
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60193-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
ALLANTOIN (UNII: 344S277G0Z)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
QUATERNIUM-15 (UNII: E40U03LEM0)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60193-102-021 in 1 CARTON
118 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C04/24/2013
Labeler - Pacific World Corporation (089693097)

Revised: 10/2014
Document Id: e078e140-0b97-46e9-99c8-de9c5593a5bb
Set id: ae22a4f1-77bd-4b37-bf3c-24f402e15bf0
Version: 3
Effective Time: 20141017
 
Pacific World Corporation