Equate Pain Relieving Patch - Lidocaine 4%

Equate Pain Relieving Patch - Lidocaine 4%
SPL v3
SPL
SPL Set ID 01e1cc0e-e1c9-d274-e063-6294a90a409e
Routes
TRANSDERMAL TOPICAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Glycerin Methylparaben Gelatin Propylene Glycol Povidone Kaolin Tartaric Acid Titanium Dioxide Water Propylparaben Sodium Polyacrylate (8000 Mw) Polyacrylic Acid (250000 Mw) Polysorbate 80 Dihydroxyaluminum Aminoacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

Lidocaine 4.0%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4.0%

Uses

Temporarily relieves minor pain

Warnings

For external use only

Questions

CALL 1-888-287-1915

Directions

Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use

Children 12 years of age or younger: Consult a physician.

Do Not Use
  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • If pouch is damaged or opened
Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Active Ingredients

Lidocaine 4.0%

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel

When Using This Product
  • Use only as directed
  • Read and follow all directions and warnings on this pack
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of used patch in manner that always keeps product away from children and pets
  • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Stop Use and Ask A Doctor If
  • Condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses (USES)

Temporarily relieves minor pain

Purpose (PURPOSE)

Topical anesthetic

Warnings (WARNINGS)

For external use only

Questions (QUESTIONS)

CALL 1-888-287-1915

Directions (DIRECTIONS)

Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use

Children 12 years of age or younger: Consult a physician.

Do Not Use (Do not use)
  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • If pouch is damaged or opened
Other Information (OTHER INFORMATION)

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Active Ingredients (ACTIVE INGREDIENTS)

Lidocaine 4.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • Use only as directed
  • Read and follow all directions and warnings on this pack
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of used patch in manner that always keeps product away from children and pets
  • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied

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

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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