NOVONAIL SOLUTION- tolnaftate 1% liquid

Novonail Solution by

Drug Labeling and Warnings

Novonail Solution by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

INDICATIONS & USAGE

For effective treatment of most athlete's foot and ringworm. Relieves itching, scaling, cracking, burning, redness, soreness, 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVONAIL SOLUTION 
tolnaftate 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-507
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)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
RICE BRAN OIL (UNII: LZO6K1506A)
SAFFLOWER OIL (UNII: 65UEH262IS)
LAVENDER OIL (UNII: ZBP1YXW0H8)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-507-01	13.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M005	03/11/2020

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(72839-507)