Csi, Pain Relieving Gel-patch, Lidocaine 4%, 6 Patches

Csi, Pain Relieving Gel-patch, Lidocaine 4%, 6 Patches
SPL v1
SPL
SPL Set ID 26c7116f-c86d-8752-e063-6294a90ab73f
Route
TOPICAL
Published
Effective Date 2024-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Edetate Disodium Hydroxyacetophenone Polysorbate 80 Glycerin Povidone K90 Kaolin Tartaric Acid Water Propylene Glycol Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Dihydroxyaluminum Aminoacetate Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

For temporary relief of pain

Warnings

For external use only

Directions

Adult and Children 12 years of age and over :

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age : Consult a doctor

Do Not Use
  • More than 1 patch at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Stop Use ... If
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days
Active Ingredient

Lidocaine 4%

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
... Ask A Doctor If
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days
Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin,Hydroxyacetophenone, Kaolin, Polysorbate80,Propylene Glycol, Polyacrylic Acid, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions Or Comments

86-21-31166566 [email protected]

When Using This Product
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
Dosage Forms & Strengths

This is a strip, patch dosage form.

The active ingredient strength is 4% w/w.

One patch one time, no more than 8 hours one time.

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 right away.

Package Label. Principal Display Panel


Structured Label Content

Uses

For temporary relief of pain

Purpose

Topical Anesthetic

Warnings

For external use only

Directions

Adult and Children 12 years of age and over :

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age : Consult a doctor

Do Not Use (Do not use)
  • More than 1 patch at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Stop Use ... If (Stop use ... if)
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days
Active Ingredient

Lidocaine 4%

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
... Ask A Doctor If (... ask a doctor if)
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days
Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin,Hydroxyacetophenone, Kaolin, Polysorbate80,Propylene Glycol, Polyacrylic Acid, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions Or Comments (Questions or Comments)

86-21-31166566 [email protected]

When Using This Product (When using this product)
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
Dosage Forms & Strengths (Dosage forms & strengths)

This is a strip, patch dosage form.

The active ingredient strength is 4% w/w.

One patch one time, no more than 8 hours one time.

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 right away.

Package Label. Principal Display Panel (Package label. Principal display panel)


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Raw Label Data

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