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FEMININE PAIN RELIEF

Menthol 10% FEMININE PAIN RELIEF PATCH

Approved
Approval ID

0c08bc4f-b99f-40cf-9cd7-06e2e8ad808f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Novamed Laboratories Private Limited

DUNS: 766401623

Products 1

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

MENTHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85267-005
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
MENTHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (2)

EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
MENTHOLActive
Quantity: 10 mg in 100 mg
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/11/2025

PRINCIPAL DISPLAY PANEL

Menthol 10% Topical Analgesic Feminine Pain Relief Patch**- NDC 85267-005-01 - Pouch Label**

!["Image Description"](/dailymed/image.cfm?name=menthol-patch- label.jpg&id=893931)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/11/2025

Uses

For temporary relief of minor aches and pains associated with:

  • menstrual cramps
  • lower pelvic pain
  • backache
  • leg cramps
  • sprains
  • strains

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/11/2025

Active Ingredient (in each patch) Purpose

Menthol 10.0%........................................Topical analgesic

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/11/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 8/11/2025

Warnings

For external use only

Use only as directed

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/11/2025

Do not use

  • on wounds or damaged skin
  • with a heating pad

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/11/2025

Ask doctor before use if you have

  • redness over affected area

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/11/2025

When using this product

  • avoid contact with eyes, mucous membranes and rashes
  • do not bandage tightly

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/11/2025

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
  • abnormal skin irritation occurs after usage

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/11/2025

**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 8/11/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/11/2025

Directions

  • adults and children 12 years of age and older apply to the affected area no more than 2 times daily
  • dry the skin at application area before applying the patch
  • open pouch and remove patch
  • peel off protective film and apply sticky side to affected area
  • children under 12 years of age consult a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/11/2025

Other Information

  • Avoid storing product in direct sunlight.
  • Protect product from excessive moisture.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/11/2025

Inactive Ingredients

  • adhesive plaster
  • eucalyptus oil

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/11/2025

Questions or Comments****Call +91 1276 457643

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/11/2025

Manufactured By:
Novamed Laboratories Pvt. Ltd.
Plot No. 03, Sector 16, HSIIDC Industrial Estate,
Bahadurgarh, Haryana – 124507 (India)

MADE IN INDIA

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