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Drug Facts
Sanamax Menthol Pain Relief Cream
FDA Label NDC 72425-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanamax Plus Llc for the product Sanamax Menthol Pain Relief Cream (NDC 72425-210). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients Menthol 4%
Otc - Purpose
Purpose Topical analgesic
Indications & Usage
Uses: temporarily relieves the minor aches and pains of muscles and
joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use: ■ on wounds, damaged, broken, or irritated skin
■ with a heating pad ■ on a child under 12 years of age with
arthritis-like conditions.
Otc - Ask Doctor
Ask a doctor before use if you have redness over the affected area.
Otc - When Using
When using this product ■ avoid contact with eyes or mucous membrane
■ do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
■ condition worsens or symptoms persist for more than 7 days
■ skin irritation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental ingestion.
If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions
■ use only as directed ■ adults and children 12 years of age and
older: apply to affected area 3 to 4 times daily
■ children under 12 years of age: ask a doctor before use
Other Safety Information
Other information:
■ Store at 68° to 77°F (20° to 25°C)
Inactive Ingredient
Inactive Ingredients:
Benzyl Alcohol, Cannabidiol, Cananga Odorata (Ylang Ylang) Flower Oil, Caprylic/
Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chamomilla Recutita (Matricaria)
Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium
Dulcis (Orange) Peel Oil, Crambe Abyssinica Seed Oil, Cymbopogon Schoenanthus
Oil, Ethyl- hexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate,
Helichrysum Italicum Flower Oil, Lavandula Angustifolia (Lavender) Oil, Lecithin,
Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, PEG-40
Hydrogenated Castor Oil, PEG-6, Phenoxyethanol, Pogostemon Cablin (Patchouli)
Oil, Polyglyceryl-3 Ricinoleate, Salvia Sclarea (Clary Sage) Oil, Sodium Acrylate/
Sodium Acryloyldimethyl Taurate Copolymer, Water/Aqua
Labeling
SanaMax
MENTHOL PAIN RELIEF CREAM
CBD 300mg
3.4 FL OZ (100mL)
Distributed by:
SanaMax Plus, LLC
McAllen, TX 78501
Questions or Comments? sanamaxplus.com
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