Tylenol Precise Warming Pain Relieving Cream

Tylenol Precise Warming Pain Relieving Cream
SPL v2
SPL
SPL Set ID 0c60b607-ade9-68f2-e063-6394a90a4025
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Cetearyl Olivate Isopropyl Palmitate Phenoxyethanol Vanillyl Butyl Ether Cetyl Alcohol Water Glycerin Carbomer Interpolymer Type A (55000 Cps) Sorbitan Olivate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-12

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

Section 55105-1

Topical analgesic

Section 55106-9

Lidocaine 4%

Warnings

For external use only.

Directions
  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Do Not Use
  • in large quantities, particularly over raw surfaces or blistered areas
Questions?

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

Other Information

store at 15 0 to 30 0 C (59 0 to 86 0 F)

Inactive Ingredients

carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, vanillyl butyl ether, water

When Using This Product
  • avoid contact with eyes
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

Principal Display Panel 113 G Tube Carton

Warming

Pain Relieving Cream

Lidocaine 4%

TYLENOL ®

PRECISE TM

Fast acting

Targeted

penetrating

pain relief

ROLLER BALL

APPLICATOR

Maximum Strength Lidocaine

without a prescription

LIGHTLY SCENTED

For external

use only

NET WT 4.0 OZ (113 g)


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

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Lidocaine 4%

Warnings

For external use only.

Directions
  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Do Not Use (Do not use)
  • in large quantities, particularly over raw surfaces or blistered areas
Questions?

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

Other Information

store at 15 0 to 30 0 C (59 0 to 86 0 F)

Inactive Ingredients

carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, vanillyl butyl ether, water

When Using This Product (When using this product)
  • avoid contact with eyes
Stop Use and Ask A Doctor If (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

Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

Warming

Pain Relieving Cream

Lidocaine 4%

TYLENOL ®

PRECISE TM

Fast acting

Targeted

penetrating

pain relief

ROLLER BALL

APPLICATOR

Maximum Strength Lidocaine

without a prescription

LIGHTLY SCENTED

For external

use only

NET WT 4.0 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

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