DERMATOOL FUNGAL NAIL TREATMENT- tolnaftate 1% liquid

Dermatool Fungal Nail Treatment by

Drug Labeling and Warnings

Dermatool Fungal Nail Treatment by is a Otc medication manufactured, distributed, or labeled by Papalo Group LLC, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

INDICATIONS & USAGE

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning, redness, sorenes, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

WARNINGS

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Stop use and ask a doctor if: irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. This product is not effective for the treatment of ringworm of the scalp or nails. 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. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

INACTIVE INGREDIENT

Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Oryza Sativa (Rice) Bran Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Simmondsia Chinensis (Jojoba) Seed Oil, BHT.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMATOOL FUNGAL NAIL TREATMENT 
tolnaftate 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84728-510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALMOND OIL (UNII: 66YXD4DKO9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
RICE BRAN OIL (UNII: LZO6K1506A)
SAFFLOWER OIL (UNII: 65UEH262IS)
LAVENDER OIL (UNII: ZBP1YXW0H8)
JOJOBA OIL (UNII: 724GKU717M)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84728-510-01	1 in 1 CARTON	04/06/2023
1		15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 84728-510-02	2 in 1 BOX	01/31/2025
2		15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3	NDC: 84728-510-03	3 in 1 BOX	02/03/2025
3		15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/06/2023

Labeler - Papalo Group LLC (119324672)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(84728-510)