Dosage and administration
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a Physician.
Soothing Pain Relief
- Manufacturer
- Clientele, Inc.
- Effective date
- 2019-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:01:59
Label at a glance#
ProductSoothing Pain Relief Roll On
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
Menthol 2%
Purpose
Topical analgesic
Indications
for the temporary relief of minor aches and pains of muscles and joints associated with
- arthritis
- simple backache
- strains
- sprains
- bruises
Warnings
- For external use only.
OTC - DO NOT USE SECTION
- Avoid contact with the eyes.
OTC - STOP USE SECTION
- 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.
OTC - WHEN USING SECTION
- Do not apply to wounds or damaged skin.
- Do not bandage tightly.
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.
Directions
- Adults and children 2 years of age and older:
apply to affected area not more than 3 to 4 times daily. - Children under 2 years of age, consult a Physician.
Inactive ingredients
Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Silica, Potassium Citrate, Magnesium Carbonate, Oleic Acid, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.
PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label
Soothing
Pain Relief
Roll-On
2 Fl Oz (59.1 ml)
Rejuvenetics™
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64483-008-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-49cb-a910-e053-dadaa90a0b85 | Soothing Pain Relief Roll On |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64483-008-02 | Soothing Pain Relief Roll On | 59.1 mL in 1 BOTTLE, DISPENSING | GEL | 59.1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Soothing Pain Relief Roll On
- MENTHOL, UNSPECIFIED FORM
- Camphor (synthetic)
- Water
- Eucalyptus oil
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64483-008 | 64483-008-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| Camphor (synthetic) | 5TJD82A1ET | IACT |
| Water | 059QF0KO0R | IACT |
| Eucalyptus oil | 2R04ONI662 | 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 |
|---|---|---|---|---|---|---|
| 1b3bb6d6-c509-4219-99e9-5e35a69fb365 | f237a74d-5c5d-4c32-a7f4-af4484988c7c | 2019-12-09 | Warnings | 1b3bb6d6-c509-4219-99e9-5e35a69fb365 f237a74d-5c5d-4c32-a7f4-af4484988c7c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.