Active Ingredient
Lidocaine HCI 4%
Pain Itch Relief Cream
FDA Label NDC 69396-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceutical Usa Llc for the product Pain Itch Relief (NDC 69396-120). 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, do not use, if pregnant or breast feeding, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
