Active Ingredient
Lidocaine 4%
Hempvana Ultra Strength Pain Relief Lotion
FDA Label NDC 73287-024
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 Hempvana Ultra Strength Pain Relief (NDC 73287-024). 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
Lidocaine 4%....................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., Glycerin, Dimethicone, Glyceryl Stearate, Caprylyl Methicone, Cannabis Sativa (Hemp) Seed Oil, Ceteth-20 Phosphate, Cetearyl Alcohol, Squalane, Tocopheryl Acetate, Phenoxyethanol, C30-45 Alkyl Cetearyl, Dimethicone Crosspolymer, Dicetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Polysorbate 60, Disodium EDTA, Aminomethyl Propanol, 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
Odor Free!
New! 5 Deep Massaging Stainless Steel Rollerballs
With 4% Lidocaine For Pain
+Hemp Seed Oil For Moisturization
Net Wt. 2.5 OZ (71 g)
1 (Hempvanarollerballs Lidocaine Page 001)
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