FLAWLESS NAILS- tolnaftate solution 
RENU LABORATORIES, INC.

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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Flawless Nails

Tolnaftate

MyFlawlessNails LLC

Fairfield, CT 06824

www.MyFlawlessNails.com

FLAWLESS NAILS

Nail Fungus Eliminator

Medical Strength

Clinically Proven

15ML (O.5FL.OZ)

Other information: Store at 68° - 77°

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.

Antifungal

Uses

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

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

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

FLAWLESS NAILS LABEL AND FLAWLESS NAILS BOX

FLAWLESS NAILS BOX

FLAWLESS NAIL LABEL

FLAWLESS NAILS 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-990
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-990-021 in 1 BOX04/03/2023
1NDC:76348-990-0115 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00504/03/2023
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES945739449manufacture(76348-990)

Revised: 1/2023
Document Id: f1875a4f-fc47-cb91-e053-2995a90addeb
Set id: f1875a4f-fc46-cb91-e053-2995a90addeb
Version: 1
Effective Time: 20230105
 
RENU LABORATORIES, INC.