Arnimax Penetrating Pain Relief Gel
FDA Label NDC 35324-274

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wynnpharm Inc. for the product Arnimax Penetrating Pain Relief Gel (NDC 35324-274). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose, uses:, warning, do not use if, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient:

Menthol 3.00%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warning

For external use only.

Do Not Use If

allergic to any ingredients listed in this product.

When Using This Product

• Use only as direcred • Avoid contact with eyes and mucous membranes • Do not apply directly to wounds or broken skin • Do not bandage tightly or use a heating pad.

Stop Use And Ask A Doctor If

• Condition worsens • Condition persists for more than 7 days or clears up and occurs again within a few days.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, seek medical attention or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

• Apply and massage a thin layer to affected area no more than 3 to 4 times daily.

• Wash hands with soap and water after applying.

Children under 12: Ask a doctor.

Other Information

• Store at 15°-25° C (59°-77°F) • Protect from heat. • Keep tightly closed.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, GLycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hydroxyethyl Cellulose, Ilex Paraguariensis (Yerba Mate') Extract, Isopropyl Myristate, Methylsulfonulmethane (MSM), Phenoxyethanol, Propylene Glycol, Triethanolamine.

Package Labeling:

Label (Label)

Label (Label)

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