Magnificent Menthol Cooling Pain Cream

Magnificent Menthol Cooling Pain Cream
SPL v2
SPL
SPL Set ID 7c5f5818-0a0b-556a-e053-2991aa0a69cc
Route
TOPICAL
Published
Effective Date 2018-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.6 g)
Inactive Ingredients
Cannabis Sativa Seed Oil Corn Oil Magnesium Chloride Mangifera Indica Seed Butter Laureth-7 Shea Butter Xanthan Gum White Wax Witch Hazel Phenoxyethanol Polyacrylamide (10000 Mw) C13-14 Isoparaffin Peppermint Grapefruit Oil Cannabidiol Water Cetearyl Glucoside Coconut Oil Olive Oil Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-12-06

Description

Menthol 5%

Purpose

Topical Analgesic


Medication Information

Indications and Usage

Uses

For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

Purpose

Topical Analgesic

Dosage and Administration

Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist.

Description

Menthol 5%

Section 51945-4

Warnings

For external use only

Directions

Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physicial or occupational therapist

  • children under 12 years of age: contact physical or occupational therapist
Active Ingredient

Menthol 5%

Inactive Ingredients:

Butyrospermum Parkii (Shea

Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol

(CBD) Extract, Cetearyl Alcohol,

Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera

(Coconut) Oil, Deionized Water, Emulsifying Wax,

Hamamelis Virginiana (Witch Hazel) Magnesium Chloride,

Mangifera Indica (Mango) Seed Butter,

Mentha piperita (Peppermint) Leaf Oil, Olea Europaea

(Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Xanthan Gum

When Using This Product

Do not bandage tightly

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

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Indications and Usage (34067-9)

Uses

For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

Dosage and Administration (34068-7)

Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist.

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physicial or occupational therapist

  • children under 12 years of age: contact physical or occupational therapist
Active Ingredient

Menthol 5%

Inactive Ingredients:

Butyrospermum Parkii (Shea

Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol

(CBD) Extract, Cetearyl Alcohol,

Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera

(Coconut) Oil, Deionized Water, Emulsifying Wax,

Hamamelis Virginiana (Witch Hazel) Magnesium Chloride,

Mangifera Indica (Mango) Seed Butter,

Mentha piperita (Peppermint) Leaf Oil, Olea Europaea

(Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Xanthan Gum

When Using This Product (When using this product)

Do not bandage tightly

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices.
Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


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