FDA Label for Triceptin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH PACKET)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND CONSULT A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN AND PETS.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Triceptin Product Label
The following document was submitted to the FDA by the labeler of this product Sola Pharmaceuticals. 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 (In Each Packet)
Lidocaine 4%
Menthol 1%
Methyl salicylate 2%
Purpose
Topical anesthetic
Topcial analgesic
Topcial analgesic
Use
Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:
- Muscle soreness
- strains
- sprains
- arthritis
- simple backache
- muscle stiffness
- bruises
Warnings
For external use only
Stomach bleeding warning: This product contains a NSAID, which may cause stomach bleeding. The chance is small, but higher if you
- are aged 60 or older
- have had stomach ulcers or bleeding problems
- take other drugs containing an NSAID (Aspirin, ibuprofen, Naproxen, or others)
- take a blood thinning (anticoagulant) or steroidal drug
- have three or more alcholic drinks every day while using this product
- take more or for a longer time than directed
Do Not Use
- More than one patch on your body at a time
- On cut, irritated or swollen skin
- On puncture wounds
- For more than one week without consulting a doctor
- If you are allergic to any active or inactive ingredients
- If pouch is damaged or opened
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
- Do not use at the same time as other topical analgesics
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use
- Do no microwave
- Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use And Consult A Doctor If
- Condition worsens
- Redness is present
- Irritation develops
- Symptoms persist for more than 7 days or clear up and occur again within a few days
- You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
- Stomach pain or upset gets worst or lasts
- You feel faint, vomit blood, or have bloody or black stools (these are signs or stomach bleeding).
If Pregnant Or Breastfeeding
ask a healthcare professional before use.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults, or children over the age of 12: Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area and leave in place for 8 to 12 hours. If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours. Only use one patch at a time. do not use more than 2 patches per day. Wash hands with soap and water after applying or removing patch. reseal pouch containing unnsed patches immediately after each use. Children under 12 years of age: Do not use.
Other Information
Store at 68°F-77°F (20°C-25°C).
Store in a clean, dry place outside of direct sunlight. Protect from excessive mositure.
Some individuals may not experience pain relief until several minutes or hours after applying the patch.
Inactive Ingredients
Arnica montana flower extract, Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-Tartaric acid, Mineral oil, Polyacrylic acid, Propylene glycol, Polysorbate 80, PVP, Sodium polyacrylate, Titanium dioxide, Water.
Questions Or Comments?
866-747-7365
Package Label.Principal Display Panel
Manufactured for:
SOLA PHARMACEUTICALS LLC
Baton Rouge, LA 70810
www.solameds.us
Made in China
Triceptin
Topical Pain Patch
for temporary pain relief
NDC 70512-017-15
Qty: 15 patches
(5 per Resealable Pouch) x 3
* Please review the disclaimer below.