Coolheat Therapy Ultra Strength Topical Pain Relief Cream
Ultra Strength Topical Pain Relief Cream
Ultra Strength Topical Pain Relief Cream
FDA Label NDC 82729-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by J C Udeozor & Sons Global Industries Ltd for the product Ultra Strength Topical Pain Relief Cream (NDC 82729-006). 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 coolheat therapy ultra strength topical pain relief cream, drug facts, active ingredients, purpose, uses, warning, do not use, ask a doctor or pharmacist before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts
Drug Facts
Active Ingredients
Active Ingredients (In each gram)
Camphor 4%
Menthol 10%
Methyl Salicylate 30%
Purpose
| Active Ingredients (In each gram) | Purpose |
| Camphor 4% | External Analgesic |
| Menthol 10% | External Analgesic |
| Methyl Salicylate 30% | External Analgesic |
Uses
Temporarily relieves minor aches & pains related to:
- arthritis
- simple backaches
- sore muscles
- joint pain
- dislocation
- leg cramps
- bruises
- sprains
Warning
For external use only.
Do Not Use
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any of the ingredients
Ask A Doctor Or Pharmacist Before Use If You Have
- sensitive skin
- redness over the affected area
When Using This Product
- avoid contact with eyes and mucous membranes
- do not bandage tightly
Stop Use And Ask A Doctor If
- rash, itching, or excessive irritation of the skin develops
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Direction
- Use only as directed
- For adults and children over 12 years, apply to the affected area 3 to 4 times daily
- Wash hands after use
- For Children under 12 years, consult a doctor before use
Inactive Ingredients
Carbomer, Disodium EDTA, Glyceryl Stearate, Lanolin,
Polysorbate 80, Potassium Hydroxide, Stearic Acid, Water
Other Information
- Store in a cool, dry place between 20 oC to 25 oC (68 oF - 77 oF)
- Do not use if the seal is broken
- See cap for lot no, mfg, and exp date
Contact Info
Distributed by:
CGE Brands
Email:
Mail:
300 Delaware Ave, Suite 210 #465
Wilmington, DE 19801
USA
Coolheat Ultra Strength Topical Pain Relief Cream
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