Indications and uses
Aid for temporary local relief of minor pain in muscles or joints.
NATUREANCE MIRACLE
- Manufacturer
- EROS GLOBAL CORP
- Effective date
- 2024-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:35:13
Label at a glance#
ProductNATUREANCE MIRACLE
Active ingredientMENTHOL
Label structure11 sections
Dosage and administration
Adults and Children over 12 years of age Apply a small amount on the affected area. Massage in circular motion, Let set for a few seconds. Repeat as necessary, but no more than 3 to 4 times daily. Children under 12 years of age: do not use, consult a doctor.
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Menthol 8%
OTC - PURPOSE SECTION
Topical Analgesic
USES:
Aid for temporary local relief of minor pain in muscles or joints.
WARNINGS SECTION
For external use only. · Ask a doctor before use if you have redness over affected area.
OTC - WHEN USING SECTION
Use only as directed.
Do not bandage tightly or use with a heating pad.
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged, broken, or irritated skin.
A transient burning sensation or redness may occur upon application but generally disappears in several days.
If you experience an allergic reaction, discontinue use, and consult a doctor.
Do not expose the area treated with product to heat or direct sunlight.
OTC - STOP USE SECTION
Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.
You experience signs injury, such as pain, swelling or blistering where the product was applied.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS:
Adults and Children over 12 years of age
Apply a small amount on the affected area.
Massage in circular motion, Let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.
Children under 12 years of age: do not use, consult a doctor.
INACTIVE INGREDIENT SECTION
Isopropyl Myristate, Fragrance (Parfum), Limonene, Pimpinella Anisum (Aniseed) Seed Oil, Mentha Piperita (Peppermint) Oil, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Oil, Ocimum Basilicum (Basil) Oil.
NATUREANCE - MIRACLE OIL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80465-008-01 | NATUREANCE MIRACLE | 28.4 g in 1 BOTTLE | OIL | 28.4 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- NATUREANCE MIRACLE
- Menthol
- ISOPROPYL MYRISTATE
- LIMONENE, (+)-
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80465-008 | 80465-008-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| LIMONENE, (+)- | GFD7C86Q1W | IACT |
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 |
|---|---|---|---|---|---|---|
| NATUREANCE MIRACLE | MENTHOL | EROS GLOBAL CORP | ec1a2a1f-a38d-9c59-e053-2a95a90ad268 | 2024-10-23 | Warnings | 80465-008-01 80465-008 80465000801 2529b5df-5b0f-94cd-e063-6394a90aee85 ec1a2a1f-a38d-9c59-e053-2a95a90ad268 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.