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

PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL by

Drug Labeling and Warnings

PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Emilia Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Tolnaftate 1%

PURPOSE

Purpose

Anti-fungal

INDICATIONS & USAGE

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

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

When using this product

    avoid contact with the eyes

   if contact occurs rinse thoroughly with water

STOP USE

Stop use and ask a doctor if

    irritation occurs and 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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

store at room temperature 15° - 30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive ingredients

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

ProClearz Anti-Fungal Shield1% Tolnaftate Anti-fungal Liquid 30 ml

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68975-181
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: 68975-181-02	1 in 1 BOX	03/10/2017
1	NDC: 68975-181-01	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	03/10/2017

Labeler - Emilia Resources, LLC (079378421)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Resources, LLC		079378421	manufacture(68975-181)