SPL v3
SPL
SPL Set ID d7fe6680-66f4-41e4-a026-711cc32c4363
Route
TOPICAL
Published
Effective Date 2010-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.25 g)
Inactive Ingredients
Aloe Avocado Oil Cyclomethicone Grape Seed Oil Methyl Salicylate Phenoxyethanol Methylparaben Shea Butter Steareth-2 Steareth-10 Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-11-01
Description

Menthol 5%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Dosage and Administration

Directions

  • adults and children 12 years of age and older:  apply to affected area no more than 3 to 4 times daily
  • children under 12 years of age: consult a physician
  • apply generously and massage into affected areas until completely absorbed
  • apply before and after sports or exercise to help soothe aching muscles, muscle strain
  • repeat as needed up to four times per day

Description

Menthol 5%

Section 44425-7

store in a cool, dry place away from direct sunlight

Section 50565-1

Keep out of reach of children.  If swallowed get medical help or contact a poison center right away.

Section 50566-9

Stop use and ask a doctor if

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

Section 50567-7

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Section 50569-3

Ask a doctor before use if you are

  • prone to allergic reactions to salicylates, including aspirin
  • using product on a child under 12 years of age

Section 50570-1

Do not use

  • on wounds or damaged skin
  • with a heating pad

Section 51727-6

Aloe, Avocado Oil, Ceteareth-20, Cyclomethicone, Grape Seed Oil, MedFlex Relief Proprietary Herbal Blend, Methyl Glucose Sesquistearate, Natural Oil of Wintergreen, Phenoxyethanol, Methylparaben, Shea Butter, Steareth-2, Steareth-10, Stearic Acid, Water

Section 51945-4

Penetrating Pain Relief

Temporary Relief of Minor Aches and Pains Associated with Arthritis, Simple Backache, Sprains, Bruises and Strains.



  • soothing and medicated analgesic rub for aching joints and muscles
  • effective for pre-exercise warm-up
  • penetrating pain relief

  • with skin moisturizing conditioners aloe, shea butter, avocado, and grape seed oil
  • contains Enzyme Labs clinically tested Panitrol herbal formula







Section 53413-1

Call 1-877-500-5529

Monday through Friday, 9am-5pm or [email protected]

Section 53414-9

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

Section 55105-1

Topical analgesic

Section 55106-9

Menthol 5%

Structured Label Content

Indications and Usage (34067-9)

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years of age and older:  apply to affected area no more than 3 to 4 times daily
  • children under 12 years of age: consult a physician
  • apply generously and massage into affected areas until completely absorbed
  • apply before and after sports or exercise to help soothe aching muscles, muscle strain
  • repeat as needed up to four times per day

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

store in a cool, dry place away from direct sunlight

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed get medical help or contact a poison center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Section 50569-3 (50569-3)

Ask a doctor before use if you are

  • prone to allergic reactions to salicylates, including aspirin
  • using product on a child under 12 years of age

Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin
  • with a heating pad

Section 51727-6 (51727-6)

Aloe, Avocado Oil, Ceteareth-20, Cyclomethicone, Grape Seed Oil, MedFlex Relief Proprietary Herbal Blend, Methyl Glucose Sesquistearate, Natural Oil of Wintergreen, Phenoxyethanol, Methylparaben, Shea Butter, Steareth-2, Steareth-10, Stearic Acid, Water

Section 51945-4 (51945-4)

Penetrating Pain Relief

Temporary Relief of Minor Aches and Pains Associated with Arthritis, Simple Backache, Sprains, Bruises and Strains.



  • soothing and medicated analgesic rub for aching joints and muscles
  • effective for pre-exercise warm-up
  • penetrating pain relief

  • with skin moisturizing conditioners aloe, shea butter, avocado, and grape seed oil
  • contains Enzyme Labs clinically tested Panitrol herbal formula







Section 53413-1 (53413-1)

Call 1-877-500-5529

Monday through Friday, 9am-5pm or [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Menthol 5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:11.642078 · Updated: 2026-03-14T22:52:33.958895