Active Ingredient
Menthol 16%
Camphor 11%
Hempvana Maximum Strength Pain Relief Cream Extreme Cream
FDA Label NDC 73287-031
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 Maximum Strength Pain Relief Cream Extreme (NDC 73287-031). 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, other safety information, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Menthol 16%..................Topical Analgesic
Camphor 11%..................Topical Analgesic
Uses
temporarily relieves minor pain associated with:■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises
Warnings
For external use only
Other Safety Information
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) tothe 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.
- Children under 2 years of age:consult a physician
- Apply generously to affected area.
- Massage into painful area until thoroughly absorbed into skin.
- Repeat as necessary, but no more than 4 times daily.
Inactive Ingredients
Water/Aqua/Eau, Alcohol Denat.,Stearic Acid, Propanediol, Steareth-21, Cetyl Alcohol, PEG-100Stearate, Glyceryl Stearate, Menthoxypropanediol, IsopropylMyristate, Hemp (Cannabis Sativa) Seed Oil, Turmeric (Curcuma
Longa) Root Extract, Phenoxyethanol, Acrylates/C10-30 Alkyl AcrylateCrosspolymer, Glycerin, Tocopheryl Acetate, Allantoin, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Sodium Hydroxide
Questions?
Questions? Call (855) 877-4503 (M-F, 9am-5pm EST)
Package Label.Principal Display Panel
Hempvana
Maximum Strength
Pain Relief
Cream Extreme
16% Menthol
11% Camphor
+ Hemp Seed Oil for moisturization
Net Wt. 3 OZ (85 g)
Outer (Hempvana Paincream Box Extreme)
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