Ak4 7

Ak4 7
SPL v1
SPL
SPL Set ID ad3d557b-71fe-7ab0-e053-2995a90acd6e
Route
TOPICAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.6 g)
Inactive Ingredients
Linalool, (+)- Caryophyllene Pinene Cetostearyl Alcohol C13-14 Isoparaffin Laureth-7 Magnesium Chloride Cannabidiol Limonene, (+)- Stearic Acid Mangifera Indica Seed Butter Coconut Oil Phenoxyethanol Polyacrylamide (10000 Mw) Witch Hazel Corn Oil Myrcene Terpineol Peg-100 Stearate White Wax Cetearyl Glucoside Shea Butter Cannabis Sativa Seed Oil Olive Oil Peppermint Oil Water Glyceryl Monostearate Tabasco Pepper

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-20
Description

Menthol 5%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses: for temporary relief of minor aches and pains associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Description

Menthol 5%

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: condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7

When using this product: Do not bandage tightly

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use heating pads or other heating devices.
Section 51727-6

Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Olus Oil (vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid.

Section 51945-4

COOLING CREAM LABEL

COOLING CREAM BOX

Section 53413-1

Questions or Comments

[email protected]

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol

5%

Directions

adults and children 12 years of age and older

  • apply generously to affected area
  • massage into painful area until thoroughy absorbed into skin
  • repeat as necessary.

Structured Label Content

Indications and Usage (34067-9)

Uses: for temporary relief of minor aches and pains associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Warnings and Precautions (34071-1)

For external use only

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: condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)

When using this product: Do not bandage tightly

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use heating pads or other heating devices.
Section 51727-6 (51727-6)

Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Olus Oil (vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid.

Section 51945-4 (51945-4)

COOLING CREAM LABEL

COOLING CREAM BOX

Section 53413-1 (53413-1)

Questions or Comments

[email protected]

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol

5%

Directions

adults and children 12 years of age and older

  • apply generously to affected area
  • massage into painful area until thoroughy absorbed into skin
  • repeat as necessary.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:31.379748 · Updated: 2026-03-14T22:58:05.187766