84165-010 Chinese Red Tiger Lidocaine Patches

84165-010 Chinese Red Tiger Lidocaine Patches
SPL v2
SPL
SPL Set ID 36b9a7a2-5832-4ce5-e063-6294a90aed12
Route
TOPICAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g) Menthol (0.01 g)
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Tartaric Acid Propylene Glycol Dihydroxyaluminum Aminoacetate Anhydrous Polyacrylic Acid (250000 Mw) Titanium Dioxide Water Mineral Oil Edetate Disodium Glycerin Hydroxyacetophenone Kaolin Povidone K90 Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-04

Description

LIDOCAINE 4% MENTHOL 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulderselbows.

Dosage and Administration



Adults and Children above 12 years old:

Clean and dry the affected area.

Tear off the protective film and apply the exposedpart of the patch to the affected area.

Carefully remove remaining film while pressingthe patch firmly on the skin.

Apply 1 patch at a time to affected area, not morethan 3 to 4 times daily.

Remove patch from the skin after at most 8-hour application

Children under age of 12:Consult a doctor

Description

LIDOCAINE 4% MENTHOL 1%

Section 50565-1

If swallowed accidentally , get medical help orcontact with Poison Control Center immediately.

Section 50566-9



localized skin reactions occur, such as rash, itching,redness, irritation, pain, swelling and blistering

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a fewdays

Section 50567-7



use only as directed

avoid contact with the eyes, mucous membranes, orrashes

do not bandage tightly

dispose of used patch in manner that always keepsproduct away from children and pets. Used patchesstill contain the drug product that can produce seriousadverse effects if a child or pet chews or ingests this patch.

Section 50570-1

more than 1 patch on your body at a time or withother topical anesthetics at the same time

on wounds or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if you are allergic to any ingredients of this product

Section 51727-6

Dihydroxyaluminum Aminoacetate

Edetate Disodium

Glycerin

Hydroxyacetophenone

Kaolin

Mineral Oil

Polyacrylic Acid

Polysorbate 80

PolyvinylPyrrolidone

Propylene Glycol

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Water

Section 51945-4

Section 55105-1

Topical anesthetic

Section 55106-9

LIDOCAINE 4%

MENTHOL 1%


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulderselbows.

Dosage and Administration (34068-7)



Adults and Children above 12 years old:

Clean and dry the affected area.

Tear off the protective film and apply the exposedpart of the patch to the affected area.

Carefully remove remaining film while pressingthe patch firmly on the skin.

Apply 1 patch at a time to affected area, not morethan 3 to 4 times daily.

Remove patch from the skin after at most 8-hour application

Children under age of 12:Consult a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed accidentally , get medical help orcontact with Poison Control Center immediately.

Section 50566-9 (50566-9)



localized skin reactions occur, such as rash, itching,redness, irritation, pain, swelling and blistering

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a fewdays

Section 50567-7 (50567-7)



use only as directed

avoid contact with the eyes, mucous membranes, orrashes

do not bandage tightly

dispose of used patch in manner that always keepsproduct away from children and pets. Used patchesstill contain the drug product that can produce seriousadverse effects if a child or pet chews or ingests this patch.

Section 50570-1 (50570-1)

more than 1 patch on your body at a time or withother topical anesthetics at the same time

on wounds or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if you are allergic to any ingredients of this product

Section 51727-6 (51727-6)

Dihydroxyaluminum Aminoacetate

Edetate Disodium

Glycerin

Hydroxyacetophenone

Kaolin

Mineral Oil

Polyacrylic Acid

Polysorbate 80

PolyvinylPyrrolidone

Propylene Glycol

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

LIDOCAINE 4%

MENTHOL 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)