Pain Relieving Roll-On Gel
Active ingredient Purpose
Menthol 10%.............Cooling Pain Reliever
Pain Relieving Roll-on Gel
FDA Label NDC 73842-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Koi Cbd Llc for the product Pain Relieving Roll-on Gel (NDC 73842-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding pain relieving roll-on gel, otc - purpose, warnings, otc - when using, otc - do not use, instructions for use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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.
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding: Ask a health professional before use.
Otc - 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
Otc - 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)
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