SPL v3
SPL
SPL Set ID cfc0bcde-ef91-1e6c-e053-2a95a90ab79e
Route
TOPICAL
Published
Effective Date 2023-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
1,1'-((1-methyl-1,2-ethanediyl)2-propenoic Acid, Bis(oxy(1-methyl-2,1-ethanediyl))) Ester

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-06
Description

Menthol (5%)

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol (5%)

Use

For the temporary relief of minor aches and pains of muscles and joins associated with:

  • cramps
  • simple backache
Section 43683-2

Directions (December 2023)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • confiditon worsens
  • redness or irritation develop
  • symptoms last more than 7 days or clear up and occur again within a few days
  • you experience burning, swelling, or blistering where applied
Section 50567-7

When using this product

  • use only as directed
  • do not use with other topical products
  • do not use on open wounds, damaged or irritated skin
  • do not bandage tightly or apply local heat to this area, like heating pads
  • in rare cases, burns have been reported for products of this type, containing menthol
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only.

Directions

Adults and children over 12 years

  • remove backing from patch
  • apply patch to affected area like abdomen or lower back
  • wear patch for up to 8 hours
  • use no more than 3-4 times daily

Children 12 years or younger: ask a doctor

Other Information
  • Store in a cool, dry place.
Active Ingredient(s)

Menthol (5%)

Inactive Ingredients

Inactive Ingredients: 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenyl acetate and 2-ethylhexyl 2-propenoate, black cohosh (cimicifuga racemosa)

Package Label Principal Display Panel

THE GOOD PATCH

2.3" x 3.7"

4-Way Stretch

Fabric Patch

Cycle

QTY. 04 PATCHES

Periods are a pain!

Get fast-acting pain relief with this water-resistant topical patch. Made with plant-derived Menthol and Black Cohosh.

Structured Label Content

Use

For the temporary relief of minor aches and pains of muscles and joins associated with:

  • cramps
  • simple backache
Section 43683-2 (43683-2)

Directions (December 2023)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • confiditon worsens
  • redness or irritation develop
  • symptoms last more than 7 days or clear up and occur again within a few days
  • you experience burning, swelling, or blistering where applied
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • do not use with other topical products
  • do not use on open wounds, damaged or irritated skin
  • do not bandage tightly or apply local heat to this area, like heating pads
  • in rare cases, burns have been reported for products of this type, containing menthol
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Topical Analgesic

Warnings

For external use only.

Directions

Adults and children over 12 years

  • remove backing from patch
  • apply patch to affected area like abdomen or lower back
  • wear patch for up to 8 hours
  • use no more than 3-4 times daily

Children 12 years or younger: ask a doctor

Other Information (Other information)
  • Store in a cool, dry place.
Active Ingredient(s)

Menthol (5%)

Inactive Ingredients (Inactive ingredients)

Inactive Ingredients: 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenyl acetate and 2-ethylhexyl 2-propenoate, black cohosh (cimicifuga racemosa)

Package Label Principal Display Panel (Package Label - Principal Display Panel)

THE GOOD PATCH

2.3" x 3.7"

4-Way Stretch

Fabric Patch

Cycle

QTY. 04 PATCHES

Periods are a pain!

Get fast-acting pain relief with this water-resistant topical patch. Made with plant-derived Menthol and Black Cohosh.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:28.830337 · Updated: 2026-03-14T23:02:04.460294