NAILENE ANTIFUNGAL TREATMENT- tolnaftate liquid

Nailene Antifungal Treatment by

Drug Labeling and Warnings

Nailene Antifungal Treatment by is a Otc medication manufactured, distributed, or labeled by Pacific World Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

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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

INGREDIENTS AND APPEARANCE

NAILENE ANTIFUNGAL TREATMENT 
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60193-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60193-102-02	1 in 1 CARTON
1		18 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	04/24/2013

Labeler - Pacific World Corporation (089693097)