Careland Hydrogel Pain Relief Patches

Careland Hydrogel Pain Relief Patches
SPL v2
SPL
SPL Set ID e970070c-1c3b-49f0-8298-e6c5ebbf50a0
Route
TOPICAL
Published
Effective Date 2024-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg) Menthol (10 mg)
Inactive Ingredients
Laurocapram Castor Oil Dihydroxyaluminum Aminoacetate Glycerin Isopropyl Myristate Polysorbate 80 Propylene Glycol Tartaric Acid Titanium Dioxide Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-10

Description

Lidocaine 4.0% Menthol 1.0%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Lidocaine 4.0% Menthol 1.0%

Use

For temporary relief of pain

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily

Children under 12 years of age:consult a doctor

Drug Facts

Do Not Use
  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Questions?

1-888-655-1558 [email protected]

Active Ingredient

Lidocaine 4.0%

Menthol 1.0%

Other Information
  • Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture
Package Labeling:

Inactive Ingredients

Azone, Castor oil, Dihydroxyaluminum Aminoacetate, Disodium edetate,Fumed silica, Glycerol, Isopropyl Myristate, Polyacrylic Acid,Polysorbate 80, Propylene Glycol,Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, water

When Using This Product
  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes, mucous membranes or rashes
Stop Use and Ask A Doctor If
  • symptoms persist for more than 7 days
  • conditions worsen
  • symptoms clear up and occur again within a few days
  • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Use

For temporary relief of pain

Purpose

Topical analgesic

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily

Children under 12 years of age:consult a doctor

Drug Facts (DRUG FACTS)

Do Not Use (Do not use)
  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Questions? (QUESTIONS?)

1-888-655-1558 [email protected]

Active Ingredient (Active ingredient)

Lidocaine 4.0%

Menthol 1.0%

Other Information (OTHER INFORMATION)
  • Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture
Package Labeling:

Inactive Ingredients (INACTIVE INGREDIENTS)

Azone, Castor oil, Dihydroxyaluminum Aminoacetate, Disodium edetate,Fumed silica, Glycerol, Isopropyl Myristate, Polyacrylic Acid,Polysorbate 80, Propylene Glycol,Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, water

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes, mucous membranes or rashes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms persist for more than 7 days
  • conditions worsen
  • symptoms clear up and occur again within a few days
  • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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