Magnificent Menthol Warming Pain Cream

Magnificent Menthol Warming Pain Cream
SPL v2
SPL
SPL Set ID 8506740a-3f42-a49f-e053-2a91aa0a0ac0
Route
TOPICAL
Published
Effective Date 2019-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-18

Description

Active Ingredient: Menthol 5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Description

Active Ingredient: 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 with heating pads or other heating devices.
Section 51727-6

Inactive Ingredients:

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil and Hemp Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens Fruit 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

Section 53413-1

Manufactured for:

X12LLC West Chester, PA 19380

www.Magx12.com

Section 55105-1

Topical Analgesic

Section 55106-9

Active Ingredient:

Menthol 5%

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 physical or occupational therapist.

children under 12 years of age: consult your physical or occupational therapist.

Magnificent Warming Layered Label Finalcorrected (2).jpg

Magnificent_Round_Warming_CBD (2).jpg

MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg


Structured Label Content

Indications and Usage (34067-9)

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

Warnings and Precautions (34071-1)

Warnings

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 with heating pads or other heating devices.
Section 51727-6 (51727-6)

Inactive Ingredients:

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil and Hemp Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens Fruit 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

Section 53413-1 (53413-1)

Manufactured for:

X12LLC West Chester, PA 19380

www.Magx12.com

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient:

Menthol 5%

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 physical or occupational therapist.

children under 12 years of age: consult your physical or occupational therapist.

Magnificent Warming Layered Label Finalcorrected (2).jpg (MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg)

Magnificent_Round_Warming_CBD (2).jpg

MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg


Advanced Ingredient Data


Raw Label Data

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