OTC - ACTIVE INGREDIENT SECTION
Miconazole Nitrate 2%
NAIL RENU ANTIFUNGAL CREAM
- Manufacturer
- RENU LABORATORIES, INC.
- Effective date
- 2023-07-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:55:53
Label at a glance#
ProductNAIL RENU Antifungal
Active ingredientMICONAZOLE NITRATE
Label structure14 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Antifungal
INDICATIONS & USAGE SECTION
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
RECENT MAJOR CHANGES SECTION
There are no major changes. This is a new submission.
WARNINGS SECTION
For external use only
OTC - WHEN USING SECTION
When using this product, avoid contact with the eyes
OTC - STOP USE SECTION
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
INSTRUCTIONS FOR USE SECTION
Directions:
- clean the affected area and dry thoroughly
- apply a thin layer over the affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- use daily for 4 weeks, if condition lasts longer, ask a doctor
- to prevent athlete's foot, apply to the feet once or twice daily
- this product is not effective on the scalp or nails
INACTIVE INGREDIENT SECTION
Benxoic Acid, Ceramide-3, Ceteareth-20, Cetearyl Alcohol, Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Dehydroacetic Acid, Deionized Water, Ethyl Macadamiate, Eucalyptol, Eugenia Caryophyllus (Clove) Bud Oil, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Fruit Oil, Origanum vulgare (Oregano) Leaf Oil, Propylene Glycol, Thymol, Tocopherol, Triethanolamine, Trimethylpentanediol Adipic Acid Copolymer, Xanthan Gum
OTC - DO NOT USE SECTION
Do not use on Children under 2 years of age unless directed by a doctor.
OTHER SAFETY INFORMATION
Other Information
Store at 68º - 77º (20 - 25 C)
STATEMENT OF IDENTITY SECTION
NAIL RENU
Miconazole Nitrate 2%
Antifungal Cream
DOSAGE & ADMINISTRATION SECTION
Directions
- Clean the affected area and dry thoroughly
- apply a thin coat over affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, change shoes and socks daily
- use daily for 4 weeks. If condition lasts longer, ask a doctor
- to prevent athlete's foot, apply to the feet once or twice daily
- this product is not effective on the scalp or nails
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76348-997-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7ba2-d83d-e063-dadaa90ab31f | NAIL RENU ANTIFUNGAL CREAM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76348-997-01 | NAIL RENU Antifungal | 28 g in 1 TUBE | CREAM | 28 | 1 | |
| 76348-997-02 | NAIL RENU Antifungal | 1 in 1 BOX | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- NAIL RENU Antifungal
- Miconazole Nitrate 2%
- POLYOXYL 20 CETOSTEARYL ETHER
- WATER
- EUCALYPTOL
- CLOVE OIL
- HIPPOPHAE RHAMNOIDES SEED OIL
- MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- OREGANO LEAF OIL
- HIPPOPHAE RHAMNOIDES FRUIT OIL
- PROPYLENE GLYCOL
- THYMOL
- TOCOPHEROL
- XANTHAN GUM
- OLIVE OIL
- MICONAZOLE NITRATE
- MICONAZOLE
- BENZOIC ACID
- CETOSTEARYL ALCOHOL
- CINNAMON BARK OIL
- DEHYDROACETIC ACID
- ETHYL MACADAMIATE
- CERAMIDE 3
- TROLAMINE
- TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76348-997 | 76348-997-01, 76348-997-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 003d6dd9-f806-3185-e063-6394a90afc94 | 003d6dd9-f805-3185-e063-6394a90afc94 | 2023-07-24 | Warnings | 003d6dd9-f806-3185-e063-6394a90afc94 003d6dd9-f805-3185-e063-6394a90afc94 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.