OP 6 MENTHOL COOLING ROLL ON
- Manufacturer
- RENU LABORATORIES, INC.
- Effective date
- 2021-08-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:41:57
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Menthol 5 percent
OTC - PURPOSE SECTION
Purpose
Topical Analgesic
INDICATIONS & USAGE SECTION
Uses
for temporary relief of minor aches and pains of muscles and joints associated with
- bruises
- sprains
- arthritis
- strains
WARNINGS SECTION
Warnings
For external use only
OTC - WHEN USING SECTION
When using this product
Do not bandage tightly
- avoid contact with eyes
- do not apply to wounds or damaged skin
- do not use with heating pads or other heating devices.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- adults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain.
- children under 12 years of age: do not use, consulta a doctor.
RECENT MAJOR CHANGES SECTION
THERE ARE NO SUBSTANTIVE LABELING CHANGES IN THE SECTION
- dosage and administration
INACTIVE INGREDIENT SECTION
Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hamamelis Virginiana (Witch Hazel), Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.
OTC - QUESTIONS SECTION
Questions? Comments?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRODUCT LABEL AND PRODUCT BOX
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 4d7a96d5-8256-4268-9a6c-25ea66d321fe | Product name | 1 | 20180814 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76348-670-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9dee-d83d-e063-dadaa90ab31f | OP 6 MENTHOL COOLING ROLL ON |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76348-670-01 | OP 6 MENTHOL COOLING ROLL ON | 1 in 1 BOX | LIQUID | 1 | 1 | |
| 76348-670-03 | OP 6 MENTHOL COOLING ROLL ON | 84 g in 1 APPLICATOR | LIQUID | 84 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- OP 6 MENTHOL COOLING ROLL ON
- MENTHOL
- LINALOOL, (+/-)-
- POLYSORBATE 80
- METHYLCELLULOSE (4000 CPS)
- MAGNESIUM SULFATE, UNSPECIFIED
- PEPPERMINT OIL
- WATER
- WITCH HAZEL
- MAGNESIUM CHLORIDE
- PINENE
- ARNICA MONTANA
- SODIUM BENZOATE
- POTASSIUM SORBATE
- ISOPROPYL ALCOHOL
- CANNABIDIOL
- LIMONENE, (+)-
- MYRCENE
- CARYOPHYLLENE
- CANNABIS SATIVA SEED OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76348-670 | 76348-670-03, 76348-670-01 |
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 |
|---|---|---|---|---|---|---|
| c9b2e269-9d3c-acc7-e053-2a95a90a0806 | c9b2eddc-691e-e1ed-e053-2a95a90ab87e | 2021-08-02 | Warnings | c9b2e269-9d3c-acc7-e053-2a95a90a0806 c9b2eddc-691e-e1ed-e053-2a95a90ab87e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

