Hempvana Cold As Ice Patch
FDA Label NDC 73287-005
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 (NDC 73287-005). 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 drug facts, active ingredient:, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Menthol 5%
Purpose
Menthol 5%................Topical Anesthetic
Uses
temporarily relief of pain
Warnings
For external use only
Otc - Do Not Use
Do not use
- more than one patch at a time
- on wounds, cuts, damaged, broken and/or irritated skin
- over raw surfaces or blistered areas
- at the same time as other topical analgesics
- if allergic to menthol or any inactive ingredients
- if package is damaged or opened
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
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 ingested, get medical help or contact a Poison Control Center right away
Directions
Adults and children over 12 years of age
- Clean and dry affected area
- follow application insructions above to apply patch to skin
- Apply one patch to affected area no more than 3-4 times daily
- Remove patch from affected area after maximum of 8 hour application
- Children uner 12 years of age: consult a doctor
Storage And Handling
- Avoid storing patches in direct sunlight. Protect patches from excessive moisture
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium polyacrylate,Tartaric Acid, Titanium Dioxide, Water
Questions?
Call (855) 877-4503 (M-F, 9am-5pm EST)
* Please review the disclaimer below.
