DERMATOOL FUNGAL NAIL SOLUTION- tolnaftate oil

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Available from:
RENU LABORATORIES, INC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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.
Authorization status:
OTC monograph final
Authorization number:
76348-584-01, 76348-584-05

Read the complete document

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.

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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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:76 348 -58 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TO LNAFTATE (UNII: 0 6 KB6 29 TKV) (TOLNAFTATE - UNII:0 6 KB6 29 TKV)

TOLNAFTATE

0 .14 g in 14 g

Inactive Ingredients

Ingredient Name

Stre ng th

RENU LABORATORIES, INC.

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

EUCALYPTO L (UNII: RV6 J6 6 0 4TK)

O REGANO LEAF O IL (UNII: 7D0 CGR40 U1)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

HIPPO PHAE RHAMNO IDES SEED O IL (UNII: T53SBG6 741)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

O LIVE O IL (UNII: 6 UYK2W1W1E)

CINNAMO N BARK O IL (UNII: XE54U56 9 EC)

CLO VE (UNII: K48 IKT5321)

THYME O IL (UNII: 2UK410 MY6 B)

TRIMETHYLPENTANEDIO L/ADIPIC ACID/GLYCERIN CRO SSPO LYMER ( 2 50 0 0 MPA.S) (UNII: 58 7WKM3S9 Q)

TEA TREE O IL (UNII: VIF56 5UC2G)

CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S)

DIETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: A1A1I8 X0 2B)

HIPPO PHAE RHAMNO IDES FRUIT O IL (UNII: TA4JCF9 S1J)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:76 348 -58 4-

1 in 1 BOX

10 /19 /20 20

1

NDC:76 348 -58 4-

14 g in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

10 /19 /20 20

Labeler -

RENU LABORAT ORIES, INC. (945739449)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RENU LABORATORIES, INC.

9 45739 449

ma nufa c ture (76 348 -58 4)

Revised: 10/2020

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