PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL- tolnaftate solution

ProClearz by

Drug Labeling and Warnings

ProClearz by is a Otc medication manufactured, distributed, or labeled by Profoot, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Anti-fungal

Uses

• cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• helps prevent most athlete's foot from recurring when used daily
• relieves itching, scaling, cracking, burning, and redness

Warnings

For external use only

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

GENERAL PRECAUTIONS

Extremely flammable

• keep away from fire or flame

When using this product

• avoid contact with the eyes
• if contact occurs rinse thoroughly with water

Stop use and ask a doctor if

• irritation occurs or if there is no improvement in 4 weeks

KEEP OUT OF REACH OF CHILDREN

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

Directions

■ shake well before using ■ wash affected area and dry thoroughly ■ apply a thin layer of the
product over affected area (around the nails and underneath nail tips) twice daily 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. If condition
persists longer, consult a doctor ■ this product is not effective on the scalp or nails

Other Information

• store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

Acetone, Aloe Vera (Aloe Barbadensis) Gel, Propylene Glycol, Tocopherol Acetate (Vitamin E), Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROCLEARZ   MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29784-181
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
ACETONE (UNII: 1364PS73AF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29784-181-02	1 in 1 BOX	10/22/2012
1	NDC: 29784-181-01	30 mL in 1 BOTTLE, WITH APPLICATOR; 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	10/22/2012

Labeler - Profoot, Inc. (107570900)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Laboratories,LLC		116933772	manufacture(29784-181)