SPL v3
SPL
SPL Set ID 1a8fe44e-7a21-c2ab-e063-6394a90a6100
Route
TOPICAL
Published
Effective Date 2024-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Black Pepper Curcuminoids Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-12

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use

for the temporary relief of pain

Dosage and Administration

Directions

  • adults and children 12 years of age and older:
  • clean and dry the affected area
  • open pouch and remove one patch
  • remove the protective backing from the patch starting at the corner
  • apply sticky side of patch to the affected area
  • reseal pouch containing unused patches after each use
  • use one patch for up to 12 hours
  • discard patch after single use
  • apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store in a clean, dry place away from direct sunlight
  • protect product from excessive moisture
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • pain, swelling, blistering or other irritation occurs where patch was applied
  • condition worsens
  • symptoms persist for more than 7 days, or clear up and occur again within a few days
Section 50567-7

When using this product

  • use only as directed
  • avoid contact with the eyes
  • do not bandage tightly
Section 50570-1

Do not use

  • on raw surfaces, blistered areas, wounds or other damaged skin
  • with a heating pad
  • more than one patch on your body at a time
  • with other topical analgesics
Section 51727-6

Inactive ingredients

black pepper extract, curcumin white, purified water, sodium chloride

Section 51945-4

curist

Lidocaine Patch

Lidocaine 4% Patch

Topical Anesthetic

Temporary Relief of Pain:

Back, Neck, Shoulders, Knees, Elbows

20 Patches

3 in x 5 in (7.6 cm x 12.7 cm) each

Section 53413-1

Questions?

Call 1-844-243-1241 or email [email protected]

Section 53414-9

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

Section 55105-1

Purpose

Topical Anesthetic

Section 55106-9

Active ingredient

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

Use

for the temporary relief of pain

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years of age and older:
  • clean and dry the affected area
  • open pouch and remove one patch
  • remove the protective backing from the patch starting at the corner
  • apply sticky side of patch to the affected area
  • reseal pouch containing unused patches after each use
  • use one patch for up to 12 hours
  • discard patch after single use
  • apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store in a clean, dry place away from direct sunlight
  • protect product from excessive moisture
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain, swelling, blistering or other irritation occurs where patch was applied
  • condition worsens
  • symptoms persist for more than 7 days, or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • avoid contact with the eyes
  • do not bandage tightly
Section 50570-1 (50570-1)

Do not use

  • on raw surfaces, blistered areas, wounds or other damaged skin
  • with a heating pad
  • more than one patch on your body at a time
  • with other topical analgesics
Section 51727-6 (51727-6)

Inactive ingredients

black pepper extract, curcumin white, purified water, sodium chloride

Section 51945-4 (51945-4)

curist

Lidocaine Patch

Lidocaine 4% Patch

Topical Anesthetic

Temporary Relief of Pain:

Back, Neck, Shoulders, Knees, Elbows

20 Patches

3 in x 5 in (7.6 cm x 12.7 cm) each

Section 53413-1 (53413-1)

Questions?

Call 1-844-243-1241 or email [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Topical Anesthetic

Section 55106-9 (55106-9)

Active ingredient

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)