Active Ingredient
Menthol USP 8% w/w
Hempvana Cold As Ice Gel
FDA Label NDC 73287-012
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 Cold As Ice Gel (NDC 73287-012). 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 - keep out of reach of children, 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 USP 8% w/w................Topical Analgesic
Uses
temporarily relief of minor aches and pains of muscles and joints associated with:
• simple backache • arthritis • strains • bruises • sprains
Warnings
For external use only
Flammable: Keep away from excessive heat or open flame
Otc - When Using
When using this product, avoid contact with eyes.
- Do not apply to wounds or damaged skin
- Do nut use in large quantities, particularly over raw surfaces or blistered areas.
- Do not bandage tightly
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or nursing, ask a healthcare professional before using.
Directions
Adults: Apply to affected are not more than 3 to 4 times daily. If product comes in contact with hands, wash with soap and water.
For children under 18 years of age: Consult a physician.
Other Information
Store tightly closed in a cool dry place.
Inactive Ingredients
water/aqua/eau, alcohol denat., isopropyl myristate, sodium hydroxide, silica silylate, hemp seed oil, camphor, aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, curcuma longa (turmeric) root extract, ilex paraguariensis leaf extract, melissa officinalis flower/leaf/stem extract, phenoxyethanol, carbomer, ethylhexylglycerin, disodium edta, tocopheryl acetate, Yellow 5 (Cl 19140), Blue 1 (Cl 42090).
Description
Call (855) 877-4503 (M-F, 9am-5pm EST)
Does not contain NSAIDS, ibuprofen, Aspirin or Salicylate
For more information visit www.hempvana.com
Dist. By: Telebrands Corp.
79 Two Bridges Road
Fairfield, NJ 07004
Package Label.Principal Display Panel
Cold Therapy For Pain
Hempvana
#1 Hemp Brand in America
Cold as Ice Pain Relief Gel
Enriched with hemp seed oil turmeric and aloe
Menthol USP 8%
For arthritis, back, shoulder, joint & muscle pain
phthalate free - paraben free - vegan - gluten free - cruelty free
4 fl oz (118 mL)
As seen on TV
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