Active Ingredients Section Otc
Methyl Salicylate 12%
Menthol USP 6%
Camphor USP 3%
Capsaicin 0.025%
Histamine Dihydrochloride 0.025%
Sombra Max Cream
FDA Label NDC 61577-3440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics Inc. for the product Sombra Max (NDC 61577-3440). 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 ingredients section otc, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
External Analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains
Warnings
For external use only. Do not use if allergic to salicylates (including aspirin), on wounds or damaged skin or with a heat source. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.
Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.
Keep Out Of Reach Of Children
Keep out of reach of children, if swallowed get medical help or contact a Posion Control Center right away.
Directions
Directions: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.
Inactive Ingredients
Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Cetearyl Alcohol, Cetyl Esters, Caprylyl Glycol, Glycerin, Phenoxyethanol, Polysorbate 60, Purified Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Yucca Schidigera Stem Extract.
Questions
1-800-225-3963
Sombra Max Package Label Principal Display Panel
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