PAIN RELIEVING ROLL-ON GEL- menthol, 10% gel

Pain Relieving Roll-On Gel by

Drug Labeling and Warnings

Pain Relieving Roll-On Gel by is a Otc medication manufactured, distributed, or labeled by Koi CBD LLC, Brad Ridenour. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Pain Relieving Roll-On Gel

Active ingredient Purpose

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

PURPOSE

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

backache arthritis strains bruises sprains

WARNINGS

Warnings: For external use only

Flammable: Keep away from excessive heat or open flame.

WHEN USING

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.

DO NOT USE

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

INSTRUCTIONS FOR USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

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

QUESTIONS

Questions or Comments? (877) 744-4779

DOSAGE & ADMINISTRATION

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

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

backache arthritis strains bruises sprains

Individual Unit Label

NDC: 73842-001-01 Roll On Bottle 89 mL

Pain Relieving Roll-On Gel 6-pack Label

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

INGREDIENTS AND APPEARANCE

PAIN RELIEVING ROLL-ON GEL 
menthol, 10% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73842-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMON LEAF OIL (UNII: S92U8SQ71V)
CITRONELLA OIL (UNII: QYO8Q067D0)
GRAPEFRUIT OIL (UNII: YR377U58W9)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)
CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
CAPSICUM OLEORESIN (UNII: UW86K581WY)
BLACK PEPPER OIL (UNII: U17J84S19Z)
BASIL (UNII: 2U0KZP0FDW)
TROLAMINE (UNII: 9O3K93S3TK)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
GINGER OIL (UNII: SAS9Z1SVUK)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
PEPPERMINT OIL (UNII: AV092KU4JH)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
CRYPTOCARYA AGATHOPHYLLA LEAF OIL (UNII: XM00Z00H98)
ROSEMARY OIL (UNII: 8LGU7VM393)
SPEARMINT OIL (UNII: C3M81465G5)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WITCH HAZEL (UNII: 101I4J0U34)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	orange (Light orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73842-001-01	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/25/2020
2	NDC: 73842-001-02	534 mL in 1 CASE; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/20/2020

Labeler - Koi CBD LLC (072518336)

Registrant - Brad Ridenour (072518336)

Establishment
Name	Address	ID/FEI	Business Operations
Koi CBD LLC		072518336	manufacture(73842-001)