MIRACURE- tolnaftate liquid

MIRACURE by

Drug Labeling and Warnings

MIRACURE by is a Other medication manufactured, distributed, or labeled by Winning Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient : Tolnaftate 1.0%

PURPOSE

Purpose : Anifungal

WARNINGS

Warnings: For external use only .

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children : Do not use on children under 2 years of age. If swallowed, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

Directions : Shake well before using, wash affected area with soap and water and dry thoroughly, apply a thin

layer over affeted area twice daily (morning and night) paying special attention to spaces between toes when used

for athlete's foot, use applicator brush to reach tight areas around and under nails, wear well-fiting, ventilated shoes,

change shoes and socks at least once daily, supervise children in the use of the product, use daily for 4 weeks; if

condition persists longer, ask a doctor, this product is not effective on the scalp or nails.

INDICATIONS & USAGE

Uses: cures most athlete's foot fungus (tinea pedis) and ringworm (tinea corporis)

effectively soothes and relieves symptoms of athlete's foot, including itching,

burningm, scaling and cracking.

INACTIVE INGREDIENT

peg-400, aloe barabardensis leaf Juice, salicylic acid, melaleuca alternifolia (tea tree) leaf oil, BHT, DMDM hydantion

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRACURE 
tolnaftate liquid

Product Information
Product Type	COSMETIC	Item Code (Source)	66391-2601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SALICYLIC ACID (UNII: O414PZ4LPZ)
TEA TREE OIL (UNII: VIF565UC2G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	66391-2601-1	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/31/2016

Labeler - Winning Solutions (962718300)

Registrant - Winning Solutions (962718300)