Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Menthol 5%
OTC - PURPOSE SECTION
Topical Analgesic
Herbal Healers Menthol Warming Roll On
- Manufacturer
- Renu Laboratories, Inc.
- Effective date
- 2022-01-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:47:01
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Uses for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.
Warnings
WARNINGS SECTION
For external use only
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Directions adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your doctor children under 12 years of age, do not use. Consult a healthcare professional.
Other Label Information
INACTIVE INGREDIENT SECTION
Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Hemp Derived Cannabigerol (CBG) Extract with proprietary terpene blend (Alpha Pinene, Beta Caryophyllene, Myrcene, Limonene, Linalool, Terpinolene), Capsicum frutescens extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil, Hydroxyethyl Celluose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Sulfate, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).
OTC - QUESTIONS SECTION
Questions ? www.HerbalHealersCBD.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
WARMING PAIN RELIEF ROLL-ON LABEL AND BOX BOX ART
Label Images#
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 |
|---|---|---|---|---|---|
| 76348-581-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9281-d83d-e063-dadaa90ab31f | Herbal Healers Warming Menthol Pain Relief Roll-on |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76348-581-01 | Herbal Healers Menthol Warming Roll On | 1 in 1 BOX | LIQUID | 1 | 2 | |
| 76348-581-03 | Herbal Healers Menthol Warming Roll On | 84 g in 1 APPLICATOR | LIQUID | 84 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
- Herbal Healers Menthol Warming Roll On
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76348-581 | 76348-581-03, 76348-581-01 |
Ingredients#
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Menthol 5%
OTC - PURPOSE SECTION
Topical Analgesic
INDICATIONS & USAGE SECTION
Uses for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.
WARNINGS SECTION
For external use only
OTC - WHEN USING SECTION
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 of if symptoms persist for more then 7 days or clear p 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 or as directed by your doctor children under 12 years of age, do not use. Consult a healthcare professional.
INACTIVE INGREDIENT SECTION
Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Hemp Derived Cannabigerol (CBG) Extract with proprietary terpene blend (Alpha Pinene, Beta Caryophyllene, Myrcene, Limonene, Linalool, Terpinolene), Capsicum frutescens extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil, Hydroxyethyl Celluose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Sulfate, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).
OTC - QUESTIONS SECTION
Questions ? www.HerbalHealersCBD.com
STATEMENT OF IDENTITY SECTION
HERBAL HEALERS Menthol WARMING Pain Relief Roll-On
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
WARMING PAIN RELIEF ROLL-ON LABEL AND BOX BOX ART