NAILRENEW (62858-101)

Manufacturer: Nailrenew Corp
Effective date: 2026-05-02
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 01:55:46

Label at a glance#

ProductNAIL RENEW

Active ingredientTOLNAFTATE

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

TOLNAFTATE 1.0%

OTC - PURPOSE SECTION

PURPOSE

ANTIFUNGAL

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS

For external use only.
In case of accidental ingestion contact a physician, emergency medical care facility or poison control center.
Stop use and ask a physician if rash or irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - DO NOT USE SECTION

DO NOT USE

ON CHILDREN UNDER 2 UNLESS DIRECTED BY A DOCTOR.
NEAR OR IN EYES, EARS OR MOUTH.

OTC - QUESTIONS SECTION

QUESTIONS? EMAIL: INFO@NAIL-RENEW.COM

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

Clean affected area with soap and warm water and dry thoroughly.
Apply 2-3 drops twice daily (morning & evening) to affected areas; especially around free edges of nails (under tips) and cuticles and the space around the toes.
Allow solution to soak into nail or skin.
This product is not effective on scalp or hair.
Application to adjacent nails is recommended to prevent the spread of the infection. Keep affected areas clean and dry throughout the day.

INACTIVE INGREDIENT SECTION

Water (Aqua), PEG-8, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Propylene Glycol, Aloe Barbadensis Leaf Juce, Coco-betaine, Octoxynol-9, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethylcellulose, Imidazolidinyl Urea, Benzyl Alcohol, Propylparaben, Triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NailRenew_BottleLabel_Front

NailRenew_BottleLabel_Back-1

NailRenew_BottleLabel_Back-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313423	tolnaftate 1 % Topical Solution	PSN	9
313423	tolnaftate 10 MG/ML Topical Solution	SCD	9
313423	tolnaftate 1 % Topical Solution	SY	9

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0748252621023	GTIN-13: 0748252621023 EAN-13: 0748252621023 GTIN-12: 748252621023 UPC-A: 748252621023 GTIN storage (14 digits): 00748252621023	NailRenew_BottleLabel_Back-1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62858-101-51	2019-12-31	C162847	48780-1	9855e2a2-4c9e-60a7-e053-dbdaa90a05bd	NAILRENEW (62858-101)
62858-101-51	2019-11-27	C162847	48780-1	9855e2a2-4c9e-60a7-e053-dbdaa90a05bd	NAILRENEW (62858-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62858-101-11	NAIL RENEW	30 mL in 1 BOTTLE	LIQUID	30		9
62858-101-51	NAIL RENEW	1 in 1 BOX	LIQUID	1		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	3
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	3
CETETH-20 PHOSPHATE	INACTIVE INGREDIENT	921FTA1500	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
COCO-BETAINE	INACTIVE INGREDIENT	03DH2IZ3FY	3
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	3
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	3
OCTOXYNOL-9	INACTIVE INGREDIENT	7JPC6Y25QS	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NAIL RENEW
TOLNAFTATE
WATER
POLYETHYLENE GLYCOL 400
GLYCERYL MONOSTEARATE
CETOSTEARYL ALCOHOL
CETETH-20 PHOSPHATE
DIHEXADECYL PHOSPHATE
PROPYLENE GLYCOL
ALOE VERA LEAF
COCO-BETAINE
OCTOXYNOL-9
CETYL ALCOHOL
STEARYL ALCOHOL
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
IMIDUREA
BENZYL ALCOHOL
PROPYLPARABEN
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62858-101	62858-101-11, 62858-101-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETETH-20 PHOSPHATE	921FTA1500	IACT
DIHEXADECYL PHOSPHATE	2V6E5WN99N	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
COCO-BETAINE	03DH2IZ3FY	IACT
OCTOXYNOL-9	7JPC6Y25QS	IACT
CETYL ALCOHOL	936JST6JCN	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	IACT
IMIDUREA	M629807ATL	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
TROLAMINE	9O3K93S3TK	IACT
TOLNAFTATE	06KB629TKV	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 183 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
OCTOXYNOL-9	OCTOXYNOL-9	7JPC6Y25QS	GEL / TOPICAL		2 mg	Exact identifier — unii+route 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route 69 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	AEROSOL, FOAM / TOPICAL		37 mg	Exact identifier — unii+route 15 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route 69 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	SHAMPOO / TOPICAL		60 mg	Exact identifier — unii+route 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route 69 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii+route 69 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	SOLUTION / TOPICAL	0.6 %w/v		Exact identifier — unii+route 3 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route 24 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route 24 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+dosage form 69 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii+route 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii+dosage form 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii+route 69 equally ranked IID candidates
OCTOXYNOL-9	OCTOXYNOL-9	7JPC6Y25QS	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii+route 69 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii+route 15 equally ranked IID candidates
COCO-BETAINE	COCO-BETAINE	03DH2IZ3FY	SHAMPOO / TOPICAL		133 mg	Exact identifier — unii+route 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii+route 69 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii+route 15 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route 15 equally ranked IID candidates
COCO-BETAINE	COCO-BETAINE	03DH2IZ3FY	SHAMPOO / TOPICAL		133 mg	Exact identifier — unii+route 3 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route 15 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii+dosage form 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii+route 69 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii+dosage form 69 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route 15 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii+route 24 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii+dosage form 24 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	OINTMENT / TOPICAL		569 mg	Exact identifier — unii+route 15 equally ranked IID candidates
IMIDUREA	IMIDUREA	M629807ATL	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route 24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAIL RENEW	TOLNAFTATE	Nailrenew Corp	a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5	2026-05-02	Warnings	Exact identifier ndc (package): 62858-101-51 ndc (package): 62858-101-11 ndc (product): 62858-101 ndc11 (package): 62858010111 ndc11 (package): 62858010151 spl id: 50dc58a9-ed7d-5126-e063-6294a90a3ad9 spl set id: a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.