TOPCARE TOLNAFTATE ANTIFUNGAL- tolnaftate cream

TopCare by

Drug Labeling and Warnings

TopCare by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• cures most athlete's foot, jock itch, and ringworm
• relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort

Warnings

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

For external use only.

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

If pregnant of breastfeeding, ask a health professional before use.

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) or as directed by a doctor
• supervise children in the 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, consult a doctor
• this product is not effective on the 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 PUNCTURED OR MISSING.

Inactive ingredients

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

Questions or comments?

866-323-0107 or www.natureplex.com

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DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

NDC: 36800-052-60

TopCare
health™

PRESCRIPTION STRENGTH

Athlete's Foot Cream

TOLNAFTATE CREAM 1% ANTIFUNGAL

OUR PHARMACISTS
RECOMMEND

NET WT 0.5 OZ (14 g)

INGREDIENTS AND APPEARANCE

TOPCARE   TOLNAFTATE ANTIFUNGAL
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-052
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
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Polyethylene glycol 400 (UNII: B697894SGQ)
Polyethylene glycol 3350 (UNII: G2M7P15E5P)
titanium dioxide (UNII: 15FIX9V2JP)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-052-60	1 in 1 CARTON	02/17/2006
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	02/17/2006

Labeler - Topco Associates LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(36800-052)