Hangzhou Rongna Health Technology Co., Ltd

Hangzhou Rongna Health Technology Co., Ltd
SPL v2
SPL
SPL Set ID 3758d625-010f-7441-e063-6394a90a066d
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-11

Description

Lidocaine 4% ...... Purpose: Topical Anesthetic

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4% ...... Purpose: Topical Anesthetic

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
  • Carefully remove backing from patch starting at a corner
  • Apply sticky side of patch to affected area.
  • Use one patch forup to 12 hours
  • Discard patch after single use

Children under 12 years of age : Consult a physician

Do Not Use
  • More than 1 patch on your body at a time
  • On cut,irritated orswollen skin
  • On puncture wounds
  • For more than oneweek without consulting a doctor
  • if you are allergic to any active or inactive ingredients
  • If the pouch is damaged or opened.
85761 159 20

85761 159 25

Stop Use ... If
  • Condition worsens
  • Redness is present
  • Irritationn develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury,suchaspain,swelling or blistering where the

    product was applied
Active Ingredient

Lidocaine 4% ...... Purpose: Topical Anesthetic

Other Information

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

... Ask A Doctor If

Condition worsens

Redness is present

Irritationn develops

Symptoms persist for more than 7 days or clear up and occur again within a few days

You experience signs of skin injury,suchaspain,swelling or blistering where the product was applied

Inactive Ingredients

Aluminum glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid,Polysorbate 80, Propylene Glycol, , Propylparaben, Povidone K90, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions Or Comments

www.chimeraguard.com

When Using This Product
  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Avoid contact with the eyes
  • Do not use with other topical analgesics at the same time
  • 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 Breast Feeding

ask a healthcare 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

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
  • Carefully remove backing from patch starting at a corner
  • Apply sticky side of patch to affected area.
  • Use one patch forup to 12 hours
  • Discard patch after single use

Children under 12 years of age : Consult a physician

Do Not Use (Do not use)
  • More than 1 patch on your body at a time
  • On cut,irritated orswollen skin
  • On puncture wounds
  • For more than oneweek without consulting a doctor
  • if you are allergic to any active or inactive ingredients
  • If the pouch is damaged or opened.
85761 159 20 (85761-159-20)

85761 159 25 (85761-159-25)

Stop Use ... If (Stop use ... if)
  • Condition worsens
  • Redness is present
  • Irritationn develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury,suchaspain,swelling or blistering where the

    product was applied
Active Ingredient

Lidocaine 4% ...... Purpose: Topical Anesthetic

Other Information (Other information)

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

... Ask A Doctor If (... ask a doctor if)

Condition worsens

Redness is present

Irritationn develops

Symptoms persist for more than 7 days or clear up and occur again within a few days

You experience signs of skin injury,suchaspain,swelling or blistering where the product was applied

Inactive Ingredients

Aluminum glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid,Polysorbate 80, Propylene Glycol, , Propylparaben, Povidone K90, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions Or Comments (Questions or Comments)

www.chimeraguard.com

When Using This Product (When using this product)
  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Avoid contact with the eyes
  • Do not use with other topical analgesics at the same time
  • 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 Breast Feeding (If pregnant or breast-feeding)

ask a healthcare 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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