DERMATOOL® FUNGAL NAIL SOLUTION

DERMATOOL Fungal Nail Solution by

Drug Labeling and Warnings

DERMATOOL Fungal Nail Solution by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERMATOOL FUNGAL NAIL SOLUTION- tolnaftate oil 
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.

----------

DERMATOOL® FUNGAL NAIL SOLUTION

Purpose

Antifungal

Uses

• Helps cure most fungal nail and skin infections, including Tinea Corporis (Ringworm) and Tinea Pedis (Athlete's Foot).
• Effectively relieves itching, burning, cracking and scaling accompanying the above conditions.

Warnings

For external use only

• Do not use on children under 2 years of age unless directed by a doctor
• Avoid contact with eyes, ears or mouth
• Stop use and ask a physician if rash or irritation occurs

KEEP OUT OF REACH OF CHILDREN

If pregnant or breastfeeding ask a health Professional before use

Directions

• Shake well before each use
• Wash and clean affected area and dry thoroughly
• Use Dermatool implements to trim nails and lightly file down the nail plate surface
• Wipe down the area clean. Do not bring nail debris onto brush or back into solution
• Apply a thin layer of antifungal solution directly to affected areas twice daily (morning and night) especially important around the edges of the nail, cuticles and the space around the nails
• Application to adjacent nails is recommended to prevent the spread of infection
• Allow solution to soak into the nail or skin then air dry
• Keep affected areas clean and dry throughout the day
• Supervise children in the use of this product.

Inactive Ingredients

C12-15 Alkyl Benzoate, Cannabis Sativa (Hemp) Seed Oil, Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Ethoxydiglycol, Eucalyptol, Eugenia Caryophyllum (Clove) Extract, Hippophae Rhamnoides (Sea Berry) Fruit & Seed Oils, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Tocopherol (Vitamin E), Trimethylpentanediol-Adipic Acid Copolymer

Tolnaftate 1 percent

Multi layer label and product box

DERMATOOL FUNGAL NAIL SOLUTION 
tolnaftate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-584
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.14 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
EUCALYPTOL (UNII: RV6J6604TK)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
TOCOPHEROL (UNII: R0ZB2556P8)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
PEPPERMINT OIL (UNII: AV092KU4JH)
OLIVE OIL (UNII: 6UYK2W1W1E)
CINNAMON BARK OIL (UNII: XE54U569EC)
CLOVE (UNII: K48IKT5321)
THYME OIL (UNII: 2UK410MY6B)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
TEA TREE OIL (UNII: VIF565UC2G)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-584-01	1 in 1 BOX	10/19/2020
1	NDC: 76348-584-05	14 g in 1 BOTTLE, WITH APPLICATOR; 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	10/19/2020	02/17/2023

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-584)

Revised: 7/2023

Document Id: 017eb77a-fcf2-6c70-e063-6294a90a639b

34390-5

Set id: b20a1f5a-a9b2-057d-e053-2995a90a8a97

Version: 3

Effective Time: 20230727