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#

ProductOP 6 MENTHOL COOLING ROLL ON
Active ingredientMENTHOL
Label structure12 sections

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRODUCT LABEL AND PRODUCT BOX

Label 2 coolingLabel 2 coolingLabel 1_cooling roll-onLabel 1_cooling roll-on

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-670-012025-01-30C16284748780-12cef2736-9dee-d83d-e063-dadaa90ab31fOP 6 MENTHOL COOLING ROLL ON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-670-01OP 6 MENTHOL COOLING ROLL ON1 in 1 BOXLIQUID11
76348-670-03OP 6 MENTHOL COOLING ROLL ON84 g in 1 APPLICATORLIQUID841

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-670OP 6 MENTHOL COOLING ROLL ON (MENTHOL) LIQUID [RENU LABORATORIES, INC.]1Legacy NDC, 2 package rows20210817_c9b2eddc-691e-e1ed-e053-2a95a90ab87e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-67076348-670-03, 76348-670-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c9b2e269-9d3c-acc7-e053-2a95a90a0806c9b2eddc-691e-e1ed-e053-2a95a90ab87e2021-08-02WarningsExact identifier
spl id: c9b2e269-9d3c-acc7-e053-2a95a90a0806
spl set id: c9b2eddc-691e-e1ed-e053-2a95a90ab87e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.