Otc - Active Ingredient
Drug Facts
Active Ingredient
Miconazole Nitrate 2%
Drug Facts
Active Ingredient
Tolnaftate 1%........................................Antifungal
The following Structured Product Label (SPL) was submitted to the FDA by Purewellness Llc for the product Purewellness Fungal Fusion Antifungal And Antimicrobial Kit (NDC 87817-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active Ingredient
Miconazole Nitrate 2%
Drug Facts
Active Ingredient
Tolnaftate 1%........................................Antifungal
Purpose .......................Antifungal
Purpose
Tolnaftate ..............Antifungal
Uses■ cures most athlete’s foot (tinea
pedis), jock itch (tinea cruris) and ringworm
(tinea corporis) ■ relieves itching, cracking,
burning and scaling, which accompany these
conditions
Uses ■ cures most athlete’s foot (tinea
pedis) relieves discomfort, irritation,
cracking, scaly skin between the toes, and
burning feet ■ clinically proven to prevent
most athlete’s foot (tinea pedis) with daily use
Warnings - For external use only
When using this product ■ avoid contact
with the eyes: rinse immediately with cool
tap water if contact occurs
Stop use and ask a doctor: If irritation
occurs or if there is no improvement within
four (4) weeks (for athlete’s foot or ringworm),
or within two (2) weeks (for jock’s itch)
Warnings - For external use only
■ on children under 2 years of age unless
directed by a physician ■ in or near the mouth
or eyes
Stop use and ask a doctor: ■ If irritation
occurs or if there is no improvement within
four (4) weeks (for athlete’s foot or ringworm).
Keep out of reach of children. If swallowed
get medical help or contact a Poison
Control Center (1-800-222-1222) right away.
Keep out of reach of children. When using
this product, avoid contact with the eyes. If
eye contact occurs, wash thoroughly with
water. If swallowed, get medical help or
contact a Poison Control Center
(1-800-222-1222) right away.
Directions■ wash the affected area with
soap and water, dry thoroughly, then apply
sparingly over the affected area ■ use twice
daily (morning and night) or as directed by a
physician ■ for athlete’s foot: pay special
attention to spaces between the toes; wear
well-fitting, ventilated shoes and change
socks at least once, daily ■ for athlete’s foot
and ringworm, use daily for four (4) weeks
■ for jock itch, use daily for two (2) weeks
■ if condition persists longer, consult a
doctor ■ this product is not effective on the
scalp or nails
Directions ■ clean the affected area and dry
thoroughly ■ apply a thin layer of the product
over the 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 ■ if condition persists
longer, consult a doctor ■ this product is not
effective on the scalp or nails to prevent
athlete’s foot: wash the foot ■ thoroughly; apply
a thin layer of the product to the feet once or
twice daily (morning and night).
Other Information■ store in dry area at
20°-28°C (68°-82°F)
Other Information ■ store at room
temperature 20-28°C (68-82°F)
Uses
Inactive Ingredients: Aloe Barbadensis Leaf
Juice, Caprylic Capric Triglyceride, Cetyl
Alcohol, Clotrimazole, Glyceryl Stearate,
Disodium EDTA, Fragrance,
Hydroxyethylcellulose, Lavendula Angustifolia
(Lavender) Flower Extract, Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Methylparaben,
PEG-100 Stearate, Polysorbate 60,
Propylparaben, Purified Water, Stearic Acid,
Tannic Acid, Triethanolamine
Inactive Ingredients:Butylparaben,
Butylated Hydroxyanisol, Butylated
Hydroxytoluene, Carthmus Tinctorius
(Safflower) Seed Oil, Ethylparaben,
Isobutylparaben, Methylparaben, Origanum
Vulgare (Oregano) Leaf Oil, Phenoxyethanol,
Propylparaben, Simmondsia Chinensis
(Jojoba) Seed Oil, Tocopherol, White Mineral Oil
Product Label for Fungal Fusion Antifungal Solution (Part 2 of 2)
-----------------------------------------
FUNGAL FUSION
Antifungal & Antimicrobial Kit
| Fungal Fusion Antifungal Solution 1 fl. oz. (30 mL) | Fungal Fusion Antifungal Cream 2 oz. (57 g) | Fungal Fusion Antimicrobial Shoe Spray 2 fl. oz. (59 mL) |
Manufactured for: Purewellness LLC
Kit
Antifungal Solution
Antifungal Cream
Shoe Spray
res
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