Tylenol Precise Pain Relieving Patch Lidocaine 4%

Tylenol Precise Pain Relieving Patch Lidocaine 4%
SPL v2
SPL
SPL Set ID 36a95afd-97e5-2271-e063-6394a90aea18
Route
TOPICAL
Published
Effective Date 2025-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Diethylene Glycol Monoethyl Ether Ethylparaben Glycerin Isopropyl Laurate Methylparaben Polysorbate 80 Povidone Propylene Glycol Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

For the temporary relief of pain

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Section 50567-7

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Section 50570-1

Do not use

  • more than one patch at a time
  • on wounds or damaged skin
  • on raw surfaces or blistered areas
  • with a heating pad
Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active ingredient

Lidocaine 4%

Warnings

For external use only.

Directions

adults and children 12 years of age and older:

children 12 to under 18 years of age, use with adult supervision

  • apply contents of one pouch to affected area not more than 3 to 4 times daily
  • remove a patch after at most 12 hours
  • single-use patch. Do not reapply
  • fold used patches so that the adhesive side sticks to itself and safely discard where children cannot get to them

children under 12 years of age: do not use

Other Information

Store at 20°C to 25°C (68°F - 77°F) ■ Open pouches are not child resistant.

Inactive Ingredients

diacetone acrylamide - acrylamidomethylpropane sulfonic acid copolymer, diethylene glycol monoethyl ether, ethylparaben, glycerin, isopropyl laurate, methylparaben, polysorbate 80, povidone, propylene glycol, water, sodium hydroxide

Questions Or Comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel Tylenol Patch Label

NEW

TYLENOL ®

PRECISE TM

Pain Relieving Patch

Lidocaine 4% Topical Analgesic

Targeted penetrating pain relief

12

Stays on for

up to 12 hours

Designed with

specialized

adhesion

technology

Maximum

Strength

Lidocaine without

a prescription

4 INDIVIDUALLY SEALED PATCHES

3.3 in X 4.4 in (8.3 cm X 11.1 cm)

See back of carton for actual size

UNSCENTED

FOR EXTERNAL USE ONLY


Structured Label Content

Uses

For the temporary relief of pain

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Section 50570-1 (50570-1)

Do not use

  • more than one patch at a time
  • on wounds or damaged skin
  • on raw surfaces or blistered areas
  • with a heating pad
Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active ingredient

Lidocaine 4%

Warnings

For external use only.

Directions

adults and children 12 years of age and older:

children 12 to under 18 years of age, use with adult supervision

  • apply contents of one pouch to affected area not more than 3 to 4 times daily
  • remove a patch after at most 12 hours
  • single-use patch. Do not reapply
  • fold used patches so that the adhesive side sticks to itself and safely discard where children cannot get to them

children under 12 years of age: do not use

Other Information

Store at 20°C to 25°C (68°F - 77°F) ■ Open pouches are not child resistant.

Inactive Ingredients

diacetone acrylamide - acrylamidomethylpropane sulfonic acid copolymer, diethylene glycol monoethyl ether, ethylparaben, glycerin, isopropyl laurate, methylparaben, polysorbate 80, povidone, propylene glycol, water, sodium hydroxide

Questions Or Comments? (Questions or comments?)

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel Tylenol Patch Label (PRINCIPAL DISPLAY PANEL - Tylenol Patch Label)

NEW

TYLENOL ®

PRECISE TM

Pain Relieving Patch

Lidocaine 4% Topical Analgesic

Targeted penetrating pain relief

12

Stays on for

up to 12 hours

Designed with

specialized

adhesion

technology

Maximum

Strength

Lidocaine without

a prescription

4 INDIVIDUALLY SEALED PATCHES

3.3 in X 4.4 in (8.3 cm X 11.1 cm)

See back of carton for actual size

UNSCENTED

FOR EXTERNAL USE ONLY


Advanced Ingredient Data


Raw Label Data

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