FDA Label for Pain Itch Relief
View Indications, Usage & Precautions
Pain Itch Relief Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceutical Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine HCI 4%
Purpose
Topical Anesthetic
Uses
Temporarily relieves minor pain
Warnings
For external use only.
When Using This Product
Use only as directed.
Do not allow contact with eyes.
Do not bandage or apply local heat such as heating pads to the area of use
Do Not Use
On large areas of the body or on cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor
If Pregnant Or Breast Feeding
Ask a health professional before 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.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adults and children over 12 years:
Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.
Children 12 years or younger: ask a doctor
Questions
For Questions please call 1 888 296 9067
Other Information
Store at room temperature
Inactive Ingredient:
Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.
Distributed By
Trifecta Pharmaceuticals USA
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
This product is not manufactured or distributed by Chattem, Inc. a Sanofi Company owner of the registered trademark Gold Bond.
* Please review the disclaimer below.