Indications and uses
For the temporary relief of pain from minor burns, sunburn, minor cuts, scrapes, and insect bites.
Topical Analgesic
- Manufacturer
- Rinati Skin, LLC
- Effective date
- 2022-10-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 23:51:16
Label at a glance#
Product4RLF Topical Analgesic
Active ingredientMENTHOL
Label structure9 sections
Dosage and administration
■ Adults and children 2 years of age or older: Apply to the desired area and gently rub into the skin, not more than 3 to 4 times daily. ■ Children under the age of 2: Consult a physician.
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS
Menthol 0.10%
PURPOSE
TOPICAL ANALGESIC
USES
For the temporary relief of pain from minor burns, sunburn, minor cuts, scrapes, and insect bites.
WARNINGS
For external use only. When using this product ■ Avoid contact with eyes. In case of eye contact, flush eyes with water. ■ If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
■ Keep out of reach of children.
If swallowed, get medical help.
DIRECTIONS FOR USE
■ Adults and children 2 years of age or older:
Apply to the desired area and gently rub into the skin, not more than
3 to 4 times daily. ■ Children under the age of 2: Consult a physician.
INACTIVE INGREDIENTS
Propylene Glycol, Ocimum Tenuiflorum Callus Culture Lysate, Glycerin, Dimethyl Sulfone, Water, Withania Somnifera Root Extract, Piper Nigrum (Pepper) Fruit Extract, Gluconolactone, Sodium Benzoate, Citric Acid, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Oil, Hydroxyethylcellulose.
OTHER INFORMATION
■ Storage Instructions: Store in a cool, dark place (<100°F). Avoid storage directly in sunlight.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76849-201-11 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-656e-198a-e063-dbdaa90aec3e | RINATI - JEUNESSE - 4RLF Topical Analgesic (76849-201) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76849-201-11 | 4RLF Topical Analgesic | 1 in 1 CARTON | CREAM | 1 | 6 | |
| 76849-201-11 | 4RLF Topical Analgesic | 10 in 1 BLISTER PACK | CREAM | 10 | 6 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- 4RLF Topical Analgesic
- MENTHOL
- PROPYLENE GLYCOL
- OCIMUM TENUIFLORUM WHOLE
- GLYCERIN
- DIMETHYL SULFONE
- WATER
- WITHANIA SOMNIFERA ROOT
- PIPER NIGRUM WHOLE
- GLUCONOLACTONE
- SODIUM BENZOATE
- CITRIC ACID MONOHYDRATE
- XANTHAN GUM
- CITRUS AURANTIUM FRUIT OIL
- CETYL HYDROXYETHYLCELLULOSE (350000 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76849-201 | 76849-201-11 |
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 |
|---|---|---|---|---|---|---|
| ec20cbf3-a0b3-2173-e053-2995a90a3ddd | ee2832c7-6347-4c67-ac2b-579e6132afaa | 2022-10-28 | Warnings | ec20cbf3-a0b3-2173-e053-2995a90a3ddd ee2832c7-6347-4c67-ac2b-579e6132afaa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.