Active Ingredient
Menthol 8%
Ultra Strength Pain Relief Gel Lotion
FDA Label NDC 73287-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Telebrands Corp for the product Ultra Strength Pain Relief Gel (NDC 73287-023). 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 active ingredient, purpose, uses, warnings, otc - when using, otc - stop 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
Purpose
Menthol 8%....................Topical Analgesic
Uses
For the temporary relief of pain
Warnings
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Otc - When Using
When using this product
- Use only as directed. Read and follow all directions and warnings on this label.
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
- Avoid contact with eyes or mucous membranes.
- Do not apply to wounds or damaged, broken or irritated skin.
- Do not use at the same time as other topical analgesics.
Otc - Stop Use
Stop use and ask a doctor if
- Condition worsens
- Symptoms persist for more than 7 days or clear up and occur again within a few days
- Redness is present or irritation develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily using roller ball applicator
- Children under 2 years of age: consult a physician
Inactive Ingredients
Water/Aqua/Eau, Alcohol Denat., Isopropyl Myristate, Cannabis Sativa (Hemp) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Arnica Montana Flower Extract,, Melissa Officinalis (Balm Mint) Extract, Camphor, Phenoxyethanol, Glycerin, Carbomer, Ethylhexylglycerin, Sodium Hydroxide, Disodium EDTA, Tocopheryl Acetate, Silica, Yellow 5 (CI 19140), Blue 1 (CI 42090)
Questions?
Call (855) 877-4503 (M-F, 9am-5pm EST)
Package Label.Principal Display Panel
#1 Hemp Pain Relief Brand in America 1
1AC Nielsen 2021 food drug mass POS
Hempvana Brand
Ultra Strength Pain Relief Lotion
NEW! 5 Deep Massaging Stainless Steel Rollerballs
Arthritis
+ Hemp Seed Oil For Moisturization
Menthol 8% For Pain
Net Wt. 2.5 OZ (71g)
* Please review the disclaimer below.
