NOVONAIL SOLUTION- tolnaftate 1% liquid 
Derma Care Research Labs, 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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Novonail Solution, Tolnaftate 1%

Tolnaftate 1%

Antifungal

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.

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).

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

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.

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.

Label

NOVONAIL SOLUTION 
tolnaftate 1% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-507
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-507-0113.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00503/11/2020
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-507)

Revised: 7/2023
Document Id: 013d6107-e3b1-0264-e063-6394a90ae1e2
Set id: 013d6107-e3b0-0264-e063-6394a90ae1e2
Version: 1
Effective Time: 20230724
 
Derma Care Research Labs, LLC