Mekesson Lidocaine Patch 6ct 95898

Mekesson Lidocaine Patch 6ct 95898
SPL v6
SPL
SPL Set ID f950b072-d978-b629-e053-6394a90abfaf
Route
TOPICAL
Published
Effective Date 2023-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Tartaric Acid Dihydroxyaluminum Aminoacetate Anhydrous Alcohol Polysorbate 80 Glycerin Propylparaben Water Titanium Dioxide Kaolin Methylparaben Sodium Polyacrylate (2500000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-01

Description

Active ingredient Purpose Lidocaine 4%..................................................................Topical anesthetic


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

  • adults and children over 12 years:
  • clean and dry affected area
  • expose a portion of the patch by firmly grasping an edge or corner and gently pull apart until backing separates
  • position and apply exposed portion of the patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch at a time, not more than 3 to 4 times daily
  • children under 12 years or younger: ask a doctor
Dosage and Administration

Distributed by: Mckesoon Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141

Product of China

Description

Active ingredient Purpose Lidocaine 4%..................................................................Topical anesthetic

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • skin reactions occur, such as pain, swelling, rash, redness, itching, irritation, or blistering where the product was applied
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • condition worsens
Section 50567-7

When using this product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • avoid the patch getting wet for better adhesion
  • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain enough lidocaine to cause serious or life-threating problems.
Section 50570-1

Do not use

  • more than 1 patch on your body at a time
  • at the same time as other topical analgesics
  • on damaged skin, or puncture wounds
  • for more than one week without consulting a doctor
  • if you are allergic to any ingredients of this product
Section 51727-6

Inactive ingredients

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate (2,500,000 MW), tartaric acid, titanium dioxide

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Use

temporarily relieves minor pain

Section 55106-9

Active ingredient Purpose

Lidocaine 4%..................................................................Topical anesthetic


Structured Label Content

Indications and Usage (34067-9)

Directions

  • adults and children over 12 years:
  • clean and dry affected area
  • expose a portion of the patch by firmly grasping an edge or corner and gently pull apart until backing separates
  • position and apply exposed portion of the patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch at a time, not more than 3 to 4 times daily
  • children under 12 years or younger: ask a doctor
Dosage and Administration (34068-7)

Distributed by: Mckesoon Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141

Product of China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • skin reactions occur, such as pain, swelling, rash, redness, itching, irritation, or blistering where the product was applied
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • condition worsens
Section 50567-7 (50567-7)

When using this product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • avoid the patch getting wet for better adhesion
  • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain enough lidocaine to cause serious or life-threating problems.
Section 50570-1 (50570-1)

Do not use

  • more than 1 patch on your body at a time
  • at the same time as other topical analgesics
  • on damaged skin, or puncture wounds
  • for more than one week without consulting a doctor
  • if you are allergic to any ingredients of this product
Section 51727-6 (51727-6)

Inactive ingredients

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate (2,500,000 MW), tartaric acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Use

temporarily relieves minor pain

Section 55106-9 (55106-9)

Active ingredient Purpose

Lidocaine 4%..................................................................Topical anesthetic


Advanced Ingredient Data


Raw Label Data

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