Active Ingredient
Menthol USP 10.0%
Pain Relieving Cold Therapy Gel
FDA Label NDC 68678-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ahc Ventures Corp Dba Cryoderm for the product Pain Relieving Cold Therapy (NDC 68678-050). 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, when using this product, stop use and ask a doctor if:, if pregnant or breast feeding, 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
Pain Reliever
Uses
Temporarily relieves minor minor aches and pains associated with
- sore musclkes and joints
- arthritis
- backache
- muscle strains
- sprains
- bruises
Warnings
For external use only
When Using This Product
Use only as directed
Do not bandage or cover the area being treated
Do not apply ice or heating pad in conjunction with this product
Do not use with any medical device or any other device
Do not combine with any other topical treatments
Avoid contact with eyes or mucous membrane
Do not apply to wounds or damaged skin
Stop Use And Ask A Doctor If:
Conditions worsens or symptoms persist for more than 7 days or clear up and recur
- Redness if present or irritation develops
If Pregnant Or Breast Feeding
Ask a healthcare professional before use
Keep Out Of Reach Of Children
In case of accidental ingestion get medical help or contact a Poison Control Center immediately
Directions - Adults And Children 2 Years Of Age And Older
Massage a liberal amount of gel directly on the skin over the affected area
- Repeat as necessary but do not apply more than 4 times daily
Children under 2 years of age: Consult a physician
Other Information
Store in a cool dry place with lid or cap closed tightly
Flammable: Keep away from excessive heat or open flame
Inactive Ingredients
Acrylates, Arnica, Boswella Serrata, Eucalyptus Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Dimethyl Sulfone(MSM), Peppermint Oil, Purified Water, SD Alcohol 39-C, Triethanolamine
Pdp
CryoDerm
Pain Relieving Cold Therapy
Gel
Fast Acting, Penetrating Pain Relief For:
Muscle Strains, Joint Pain, Backachke, Arthritis, Sprained Ligaments & Bruises.
Contains Essential Oils and Natural Extracts
MSM Arnica Boswellia Ilex
Active Ingredient: Menthol
32 fl. oz. 1.0L
* Please review the disclaimer below.
