Active Ingredient
Lidocaine HCI 4%
Pain Relief Gel-roll On Gel
FDA Label NDC 69396-188
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 Pharmaceuticals Usa for the product Pain Relief Gel-roll On (NDC 69396-188). 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, keep out of reach of children, if pregnant or breast feeding, warning section, directions, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Keep Out Of Reach Of Children
If Swallowed, get medical help or contact a Poison Control Center right away
If Pregnant Or Breast Feeding
If Pregnant or breast feeding as a doctor before use.
Warning Section
For External Use Only
Flammable - keep away from fire or flames.
Directions
- Adults and children over 12 years: apply a thin layer to the affected area not more than 3 to 4 times daily.
- Children 12 years or younger: ask a doctor
Do Not Use
Do Not Use
- On large areas of the body or on cut, irritatied or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
When Using This Product
When using this product
- use only as directed. Read and follow all directions and warnings on this carton
- Do not allow contact with the eyes and mucous membranes
- do not bandage or apply local heat (such as heating pads) or a medicated patch to the area of use.
- Do not use at the same time as other topical analgesics.
Indications And Use
Temporarily relieves minor pain.
Other Information
- Store at 20° to 25°C (68° to 77°F)
Inactive Ingredient:
Aloe Vera Extract, Carbomer, Isopropyl Myristate, Polysorbate 80, Propylene glycol, Vitamin E, Water, 1,2 Hexanediol, Aminomethylpropanol, Butylene Glycol, Cetostearyl alcohol, Dimethicone, Edetate Disodium, Glycerin, Glycerol Mono and Dipalmitostearate, hydroxyacetophenone
Stop Use And Ask Doctor If
Stop use and ask doctor if
- Condition worsens
- Redness is present
- irritation devlops
- symptoms persisit for more than 7 days or clear up and occur again within a few days
Questions?
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA ®
101 NE Third Avenue, Suite 1500
Fort Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
SKU: 6003
* This product is not manufactured or distributed by Chattem Inc., the distributor of Aspercreme®
* Please review the disclaimer below.
