Magsoothium Body Cream

Magsoothium Body Cream
SPL v3
SPL
SPL Set ID f604d30c-b17c-ec01-e053-2a95a90aa304
Route
TOPICAL
Published
Effective Date 2023-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.032 g) Menthol (2 g)
Inactive Ingredients
Polyglyceryl-2 Stearate Magnesium Sulfate, Unspecified Magnesium Chloride Arnica Montana Flower Propanediol Polysorbate 60 Palmitic Acid 1,2-hexanediol Caprylhydroxamic Acid Soybean Oil Cetostearyl Alcohol .alpha.-tocopherol Acetate Water Cannabis Sativa Seed Oil Olive Oil Coconut Oil Polyglycerin-3 Peppermint Oil Phenoxyethanol Ethylhexylglycerin Mangifera Indica Seed Butter Stearic Acid Peg-100 Stearate Tabasco Pepper Xanthan Gum Glycerin Glyceryl Monostearate Stearyl Alcohol Hamamelis Virginiana Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01

Description

Active Ingredient Menthol USP 2.0% Capsaicin 0.032% Purpose Topical Analgesic


Medication Information

Warnings and Precautions

Warnings For external use only

When using this product use only as directed

  • Do not bandage or cover the area being treated
  • Do not apply ice or heating pad in conjunction with this product.
  • Do not use with any medical device or other device
  • Do not combine with any other topical treatment
  • Avoid contact with eyes or mucous membrane
  • Do not apply to wounds or damaged skin

If pregnant or breast-feeding Ask a health professional before use

Indications and Usage

Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days or clear up and recur

Redness is present or irritation develops

Dosage and Administration

Directions - Adults and children 2 years of age and older

Apply directly onto affected area without the need to rub, massage or bandage

  • repeat as necessary but do not apply more than 4 times daily

Children under 2 years of age Consult a physician

Description

Active Ingredient Menthol USP 2.0% Capsaicin 0.032% Purpose Topical Analgesic

Section 50565-1

Keep out of reach of children. In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Section 51727-6

Inactive Ingredients Water, Cannabis Sativa Seed Oil, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Glycerin, Glyceryl Stearate, Polyglyceryl-2 Stearate, PEG-100 Stearate, Mangifera indica (Mango) Seed Butter, Palmitic Acid, Stearic Acid, Stearyl Alcohol, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Capsicum Frutescens Fruit, Arnica Montana Flower Extract, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Magnesium Chloride, Xanthan Gum, Tocopheryl Acetate, Polyglycerin-3, Glycine Soja (Soybean) Oil, Propanediol, Cetearyl Acohol, Polysorbate 60, 1,2-Hexanediol, Caprylhydroxamic Acid

Section 51945-4

Homeopathic Pain Reliever

Magsoothium CBD Warming Formula

Magsoothium Body Cream

Helps relieve minor aches & pains

Net Contents: 4 oz (112 ml)

Section 55105-1

Uses Temporary relieves minor aches and pains associated with

  • Sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises
Section 55106-9

Active Ingredient

Menthol USP 2.0%

Capsaicin 0.032%



Purpose

Topical Analgesic


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days or clear up and recur

Redness is present or irritation develops

Dosage and Administration (34068-7)

Directions - Adults and children 2 years of age and older

Apply directly onto affected area without the need to rub, massage or bandage

  • repeat as necessary but do not apply more than 4 times daily

Children under 2 years of age Consult a physician

Warnings and Precautions (34071-1)

Warnings For external use only

When using this product use only as directed

  • Do not bandage or cover the area being treated
  • Do not apply ice or heating pad in conjunction with this product.
  • Do not use with any medical device or other device
  • Do not combine with any other topical treatment
  • Avoid contact with eyes or mucous membrane
  • Do not apply to wounds or damaged skin

If pregnant or breast-feeding Ask a health professional before use

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Section 51727-6 (51727-6)

Inactive Ingredients Water, Cannabis Sativa Seed Oil, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Glycerin, Glyceryl Stearate, Polyglyceryl-2 Stearate, PEG-100 Stearate, Mangifera indica (Mango) Seed Butter, Palmitic Acid, Stearic Acid, Stearyl Alcohol, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Capsicum Frutescens Fruit, Arnica Montana Flower Extract, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Magnesium Chloride, Xanthan Gum, Tocopheryl Acetate, Polyglycerin-3, Glycine Soja (Soybean) Oil, Propanediol, Cetearyl Acohol, Polysorbate 60, 1,2-Hexanediol, Caprylhydroxamic Acid

Section 51945-4 (51945-4)

Homeopathic Pain Reliever

Magsoothium CBD Warming Formula

Magsoothium Body Cream

Helps relieve minor aches & pains

Net Contents: 4 oz (112 ml)

Section 55105-1 (55105-1)

Uses Temporary relieves minor aches and pains associated with

  • Sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises
Section 55106-9 (55106-9)

Active Ingredient

Menthol USP 2.0%

Capsaicin 0.032%



Purpose

Topical Analgesic


Advanced Ingredient Data


Raw Label Data

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