FLAWLESS NAILS- tolnaftate solution

FLAWLESS NAILS by

Drug Labeling and Warnings

FLAWLESS NAILS by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC., RENU LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate

QUESTIONS

MyFlawlessNails LLC

Fairfield, CT 06824

www.MyFlawlessNails.com

STATEMENT OF IDENTITY

FLAWLESS NAILS

Nail Fungus Eliminator

Medical Strength

Clinically Proven

15ML (O.5FL.OZ)

OTHER SAFETY INFORMATION

Other information: Store at 68° - 77°

INACTIVE INGREDIENT

Inactive Ingredients

C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonium Zeylanicum (Cinnamon Bark) Oil, Cymbopogon Nardus (Citronella) Oil, Ethoxydiglycol, Eugenia Caryophyllum (Clove Bud) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Lavandula Angustifolia (Lavender) Oil, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Leaf Oil,

Olea Europaea (Olive Pomace) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Pinene, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromaticum (Clove Bud) Oil, Thymol, Tocopherol Acetate, Trimethyl-Adipic Acid Copolymer.

PURPOSE

Antifungal

INDICATIONS & USAGE

Uses

• proven clinically to cure most:
• athlete's foot (tinea pedis)
• ringworm (tinea corporis)

• Effectively soothes and relieves:
• itching
• burning
• cracking
• helps prevent most athlete's foot from coming back with daily use

WARNINGS

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 the eyes

Stop use and ask a doctor if

• there is no improvement within 4 weeks

Keep out of reach of children.

Get medical help or contact a Poison Control Center right away.

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

When using this product, avoid contact with the eyes

Keep out of reach of children.

Get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

clean the affected area and dry thoroughly

apply a thin layer over the affected area twice daily

supervise children in the use of this product

for athletes foot pay special attention to the spaces between toes

use daily for 4 weeks

PRINCIPAL DISPLAY PANEL

FLAWLESS NAILS LABEL AND FLAWLESS NAILS BOX

INGREDIENTS AND APPEARANCE

FLAWLESS NAILS 
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-990
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
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CINNAMON BARK OIL (UNII: XE54U569EC)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
PINENE (UNII: 996299PUKB)
ALMOND OIL (UNII: 66YXD4DKO9)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CLOVE (UNII: K48IKT5321)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TEA TREE OIL (UNII: VIF565UC2G)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CITRONELLA OIL (UNII: QYO8Q067D0)
CERAMIDE 3 (UNII: 4370DF050B)
OLIVE OIL (UNII: 6UYK2W1W1E)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
JOJOBA OIL (UNII: 724GKU717M)
CLOVE OIL (UNII: 578389D6D0)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-990-02	1 in 1 BOX	04/03/2023
1	NDC: 76348-990-01	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 final	M005	04/03/2023

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES		945739449	manufacture(76348-990)