the body builder's cream

the body builder's cream
SPL v1
SPL
SPL Set ID f803325e-eb86-4b9e-a401-0a91bdcd6389
Route
topical
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (100 mg)
Inactive Ingredients
aloe vera leaf juice arnica montana whole caprylyl glycol carbomer homopolymer, unspecified type dimethyl sulfone edetate disodium glycerin glyceryl laurate ilex paraguariensis leaf isopropyl alcohol tea tree oil polysorbate 20 pyridoxine hydrochloride .alpha.-tocopherol acetate trolamine water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-03

Purpose

Topical Analgesic

Description

Menthol 10.00%


Medication Information

Purpose

Topical Analgesic

Description

Menthol 10.00%

Questions?
Uses:

For the temporary relief of minor aches and pains of muscles and joints

Warnings:

For external use only

Do Not Use

on damaged or broken skin.

Drug Facts

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Package Labeling:

Active Ingredients

Menthol 10.00%

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Caprylyl Glycol, Carbomer, Dimethyl Sulfone, Disodium EDTA, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polysorbate 20, Pyridoxine HCl, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

When Using This Product

Avoid contact with the eyes. Do not bandage tightly.

Stop Use and Ask A Doctor If

rash or irritation develops and lasts. condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

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


Structured Label Content

Purpose

Topical Analgesic

Questions?
Uses:

For the temporary relief of minor aches and pains of muscles and joints

Warnings:

For external use only

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Package Labeling:

Active Ingredients

Menthol 10.00%

Other Information: (Other information:)

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Caprylyl Glycol, Carbomer, Dimethyl Sulfone, Disodium EDTA, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polysorbate 20, Pyridoxine HCl, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

When Using This Product (When using this product)

Avoid contact with the eyes. Do not bandage tightly.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash or irritation develops and lasts. condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

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.


Advanced Ingredient Data


Raw Label Data

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