MedPath

Pain Relief

73557-175

Approved
Approval ID

3ed51136-ea8e-8101-e063-6394a90acd4c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 22, 2025

Manufacturers
FDA

Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

DUNS: 546872672

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine and Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73557-175
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine and Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 22, 2025
FDA Product Classification

INGREDIENTS (16)

KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUSInactive
Code: 1K713C615K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
MENTHOLActive
Quantity: 0.01 g in 1 g
Code: L7T10EIP3A
Classification: ACTIB
LIDOCAINEActive
Quantity: 0.04 g in 1 g
Code: 98PI200987
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

Package label. Principal display panel

patch175-20

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Uses

For temporary relief of pain

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active Ingredient

Lidocaine 4% w/w ...... Purpose: Topical anesthetic

Menthol 1% w/w ...... Purpose: Topical analgesic

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purposes

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/15/2025

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/15/2025

Do not use:

  • More than 1 patch at a time
  • On wounds or damaged skin
  • For more than one week without consulting a doctor
  • If you are allergic to any ingredients of this product

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/15/2025

Stop use and ask a doctor if:

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Condition worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/15/2025

If pregnant or breast-feeding,

Ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/15/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive Ingredients

Dihydroxyaluminium Aminoacetate, Edetate Disodium,Glycerin, Hydroxyacetophenone,Kaolin, Mineral Oil,Polysorbate 80, Polyacrylic Acid, Povidone K90, Propylene Glycol,Sodium Polyacrylate,Tartaric Acid,Titanium Dioxide,Water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2025

Questions or Comments

service@newtrendsmed.com

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/15/2025

Other information

  • Store at 68-77℉ (20-25℃)
  • Store in a cool dry place away from direct sunlight

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Pain Relief - FDA Drug Approval Details