SPL v5
SPL
SPL Set ID 17cd35f6-e0d3-4875-9ca6-1d47d352d7d3
Route
TOPICAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 mg)
Inactive Ingredients
Camphor (synthetic) Carbomer 940 D&c Yellow No. 10 Fd&c Yellow No. 5 Glycerin Isopropyl Myristate Methyl Salicylate Methylchloroisothiazolinone Methylisothiazolinone Polysorbate 20 Propylene Glycol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-01

Description

Active Ingredient Menthol 5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child 12 years of age and under
  • over extensive areas of the body
  • on irritated skin
  • with a bandage
  • with other ointments, creams, sprays or liniments

Ask a doctor before use if you have redness over the affected area.

When using this product

  • wash hands after use with cool water
  • avoid contact with eyes or mucous membranes
  • do not bandage

Stop use and ask a doctor if

  • condition worsens or symptoms persists for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
Indications and Usage

Uses

  • for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthristis, strains and sprains.
Dosage and Administration

Directions

  • use only as directed
  • Adults and children over 12 years: rub a thin film over affected areas not more than 4 times daily: message not necessary.
  • Children 12 years or younger: do not use. 
Description

Active Ingredient Menthol 5%

Section 50565-1

Keep out of reach of children to avoid accidental poisoning. If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients Camphor, carbomer 940, D&C yellow #10, FD&C yellow #5, glycerin, isopropyl myristate, methyl salicylate, methylchloroisothiazolinone, methlylisothiazolinone, polysorbate 20, propylene glycol, triethanolamine, water.

Section 51945-4

Section 53413-1

Questions? Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

Section 53414-9

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

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active Ingredient

Menthol 5%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthristis, strains and sprains.
Dosage and Administration (34068-7)

Directions

  • use only as directed
  • Adults and children over 12 years: rub a thin film over affected areas not more than 4 times daily: message not necessary.
  • Children 12 years or younger: do not use. 
Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child 12 years of age and under
  • over extensive areas of the body
  • on irritated skin
  • with a bandage
  • with other ointments, creams, sprays or liniments

Ask a doctor before use if you have redness over the affected area.

When using this product

  • wash hands after use with cool water
  • avoid contact with eyes or mucous membranes
  • do not bandage

Stop use and ask a doctor if

  • condition worsens or symptoms persists for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning. If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients Camphor, carbomer 940, D&C yellow #10, FD&C yellow #5, glycerin, isopropyl myristate, methyl salicylate, methylchloroisothiazolinone, methlylisothiazolinone, polysorbate 20, propylene glycol, triethanolamine, water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient

Menthol 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)