Careland Lidocaine 4% Pain Relieving Gel-patches

Careland Lidocaine 4% Pain Relieving Gel-patches
SPL v5
SPL
SPL Set ID a6ca8382-7ce5-4df9-912e-8a0ac0423116
Route
TOPICAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Polysorbate 80 Povidone K90 Propylene Glycol Propylparaben Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-06

Description

Lidocaine 4.0%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4.0%

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
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove film from patch and apply to the skin
  • Children under 12 years of age: consult a doctor

Drug Facts

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

1-888-655-1558

Active Ingredient

Lidocaine 4.0%

Other Information
  • store in a clean, dry place outside of direct sunlight, Protect product from excessive moisture
Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone K90, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, 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
Package Labeling:75568 004 01

Package Labeling:75568 004 02

Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding, 

ask a health professional before use


Structured Label Content

Use

For temporary relief of pain

Purpose

Topical anesthetic

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)

Adults and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove film from patch and apply to the skin
  • 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
  • with a heating pad
  • on wounds or damaged skin
  • ir you are allergic to any ingredients of this product
Questions? (QUESTIONS?)

1-888-655-1558

Active Ingredient

Lidocaine 4.0%

Other Information (OTHER INFORMATION)
  • store in a clean, dry place outside of direct sunlight, Protect product from excessive moisture
Inactive Ingredients (INACTIVE INGREDIENTS)

Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone K90, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, 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
Package Labeling:75568 004 01 (Package Labeling:75568-004-01)

Package Labeling:75568 004 02 (Package Labeling:75568-004-02)

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.

If Pregnant Or Breast Feeding,  (If pregnant or breast feeding, )

ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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