NATUREPLEX TOLNAFTATE ANTIFUNGAL- tolnaftate cream

NATUREPLEX TOLNAFTATE by

Drug Labeling and Warnings

NATUREPLEX TOLNAFTATE by is a Otc medication manufactured, distributed, or labeled by Natureplex, LLC, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• cures most athlete's foot, jock itch, and ringworm
• relieves itching, burning, cracking, scaling, and discomfort that accompany these conditions

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or, contact a Poison Control Center right away: 800-222-1222.

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night)
• supervise children in use of this product
• for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if condition persists longer, ask a doctor
• this product is not effective on scalp or nails

Other information

• store at 15°to 30°C (59°to 86°F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol, petrolatum

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Natureplex™

TOLNAFTATE

Antifungal Cream

NET WT. 1 Oz. (28g)

INGREDIENTS AND APPEARANCE

NATUREPLEX TOLNAFTATE   ANTIFUNGAL
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-032
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 g

Inactive Ingredients
Ingredient Name	Strength
CETETH-20 (UNII: I835H2IHHX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-032-01	1 in 1 CARTON	09/23/1993
1		28 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	09/23/1993

Labeler - Natureplex, LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-032)