Fei Lidocaine&menthol Pain Relief Gel-patch, 5 Patches

Fei Lidocaine&menthol Pain Relief Gel-patch, 5 Patches
SPL v1
SPL
SPL Set ID db72a44e-a827-9fa5-e053-2995a90aa7de
Route
TOPICAL
Published
Effective Date 2022-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.03 g) Lidocaine (0.12 g)
Inactive Ingredients
Kaolin Tartaric Acid Water Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Mineral Oil Polysorbate 80 Glycerin Edetate Disodium Povidone K90 Hydroxyacetophenone

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-04-05

Description

Lidocaine 4.0% w/w ...... Purpose: Topical anesthetic Menthol 1.0% w/w ...... Purpose: Topical analgesic

Purpose

Topical anesthetic (Lidocaine) Topical analgesic (Menthol)


Medication Information

Purpose

Topical anesthetic (Lidocaine) Topical analgesic (Menthol)

Description

Lidocaine 4.0% w/w ...... Purpose: Topical anesthetic Menthol 1.0% w/w ...... Purpose: Topical analgesic

Uses

Temporarily relieves minor pain

Purposes

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Warnings

For external use only

Directions

Adult and Children 12 years of age and over:

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply stickly side of patch to affected area. Use one patch for up to 12 hours.

Children under 12 years of age: 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.
Active Ingredient

Lidocaine 4.0% w/w ...... Purpose: Topical anesthetic

Menthol 1.0% w/w ...... Purpose: Topical analgesic

Other Information

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

Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide, Polysorbate 80, Mineral Oil, Propylene Glycol, L(+)-Tartaric Acid, Polyacrylic Acid, PolyvinylPyrrolidone K90, Hydroxyacetophenone, Water

When Using This Product
  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes
  • Do not use at the same time as other 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.
If Pregnant Or Breastfeeding,

ask a health professional before use.

Stop Use and Consult A Doctor If
  • Condition worsen
  • 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 applied.
Keep Out of Reach of Children and Pets

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

Package Label. Principal Display Panel


Structured Label Content

Uses

Temporarily relieves minor pain

Purposes

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Warnings

For external use only

Directions

Adult and Children 12 years of age and over:

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply stickly side of patch to affected area. Use one patch for up to 12 hours.

Children under 12 years of age: 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.
Active Ingredient (Active ingredient)

Lidocaine 4.0% w/w ...... Purpose: Topical anesthetic

Menthol 1.0% w/w ...... Purpose: Topical analgesic

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide, Polysorbate 80, Mineral Oil, Propylene Glycol, L(+)-Tartaric Acid, Polyacrylic Acid, PolyvinylPyrrolidone K90, Hydroxyacetophenone, Water

When Using This Product (When using this product)
  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes
  • Do not use at the same time as other 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.
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • Condition worsen
  • 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 applied.
Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

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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