PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL- tolnaftate solution liquid 
Emilia Resources, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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 and there is no improvement in 4 weeks

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

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

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

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PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL 
tolnaftate solution liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68975-181
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETONE (UNII: 1364PS73AF)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68975-181-021 in 1 BOX03/10/201712/30/2022
1NDC:68975-181-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/10/201712/30/2022
Labeler - Emilia Resources, LLC (079378421)
Establishment
NameAddressID/FEIBusiness Operations
Emilia Resources, LLC079378421manufacture(68975-181)

Revised: 7/2023
 
Emilia Resources, LLC