Pain Relieving Roll-On Gel

Manufacturer
Koi CBD LLC | Brad Ridenour
Effective date
2020-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:41

Label at a glance#

ProductPain Relieving Roll-On Gel
Active ingredientMENTHOL
Label structure14 sections

Label contents#

Full prescribing information#

Pain Relieving Roll-On Gel

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Menthol 10%.............Cooling Pain Reliever

OTC - PURPOSE SECTION

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with:

• backache • arthritis • strains • bruises • sprains

WARNINGS SECTION

Warnings: For external use only

Flammable: Keep away from excessive heat or open flame.

OTC - WHEN USING SECTION

When using this product: Avoid contact with the eyes. 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 product and consult a physician. Do not apply to wounds or damaged skin. Do not bandage tightly.

OTC - DO NOT USE SECTION

Do not use in eyes. In case of contact, rinse thoroughly with water.

INSTRUCTIONS FOR USE SECTION

Directions

Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding: Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

OTHER SAFETY INFORMATION

Store in a cool dry place with lid closed tightly.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic Aloe Leaf Juice, Ethyl Alcohol, White Camphor Essential Oil, Meadowfoam Seed Oil, Cannabidiol (CBD)

from Hemp Extract, Capsicum Fruit Oleoresin, Sweet Basil Leaf Oil, Black Pepper Oil, Roman Chamomile Flower Oil, German Chamomile Flower Oil, Cinnamon Leaf Oil, Citronella Oil, Eucalyptus Leaf Oil, Helichrysum Flower Oil, Ginger Root Oil, Pink Grapefruit Peel Oil, Juniper Berry Oil, Lemongrass Oil, Peppermint Oil, Pine Needle Oil, Ravensara Oil, Rosemary Leaf Oil, Spearmint Oil, Wild Oregano Oil, Glycerin, Witch Hazel Water, Organic Alcohol, Phenoxyethanol, Carbomer, Triethanolamine, Tetrasodium Glutamate Diacetate

OTC - QUESTIONS SECTION

Questions or Comments? (877) 744-4779

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

INDICATIONS & USAGE SECTION

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with:

• backache • arthritis • strains • bruises • sprains

Individual Unit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 73842-001-01 Roll On Bottle 89 mL

Pain Relieving Roll-On Gel LabelPain Relieving Roll-On Gel Label

Pain Relieving Roll-On Gel 6-pack Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 73842-001-02 Case of 6 bottles (Net Vol. 534 mL)

Pain Relieving Roll-On Gel 6-pack LabelPain Relieving Roll-On Gel 6-pack Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73842-001-012022-01-28C16284748780-1d6a99b39-da2e-a426-e053-dadaa90af4c2Koi Muscle Gel Roll-On
73842-001-022022-01-28C16284748780-1d6a99b39-da2e-a426-e053-dadaa90af4c2Koi Muscle Gel Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73842-001-01Pain Relieving Roll-On Gel89 mL in 1 BOTTLE, WITH APPLICATORGEL891
73842-001-02Pain Relieving Roll-On Gel534 mL in 1 CASEGEL5341

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73842-001PAIN RELIEVING ROLL-ON GEL (MENTHOL, 10%) GEL [KOI CBD LLC]1Legacy NDC, 2 package rows20200527_a33a18d7-3a97-6609-e053-2995a90a2e87.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73842-00173842-001-01, 73842-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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
a33a12ac-d06a-94c5-e053-2995a90a1b39a33a18d7-3a97-6609-e053-2995a90a2e872020-03-19WarningsExact identifier
spl id: a33a12ac-d06a-94c5-e053-2995a90a1b39
spl set id: a33a18d7-3a97-6609-e053-2995a90a2e87

Reported adverse events (FAERS/openFDA)#

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