Triceptin Patch

Triceptin Patch
SPL v4
SPL
SPL Set ID ef1b98ab-d2db-038c-e053-2995a90a94b4
Route
TOPICAL
Published
Effective Date 2022-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg) Salicylic Acid (20 mg) Menthol (10 mg)
Inactive Ingredients
Arnica Montana Flower Propylene Glycol Titanium Dioxide Water Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Mineral Oil Polyacrylic Acid (250000 Mw) Povidone K90 Sodium Polyacrylate (2500000 Mw) Hydroxyacetophenone Kaolin Tartaric Acid Polysorbate 80

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-05

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

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
Section 51945-4

​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

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
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.

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
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

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.
If Pregnant Or Breastfeeding

ask a healthcare professional before use.

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).
Active Ingredient (in Each Packet)

Lidocaine 4%

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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
Section 51945-4 (51945-4)

​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

Purpose

Topical anesthetic

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
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.

Do Not Use (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
Other Information (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 (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? (Questions or comments?)

866-747-7365

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
  • 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.
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a healthcare professional before use.

Stop Use and Consult A Doctor If (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).
Active Ingredient (in Each Packet) (Active ingredient (in each packet))

Lidocaine 4%

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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