Otc - Active Ingredient
Capsicum 0.13%
Methyl Salicylate 10.5%
Menthol 5%
Zaxs Aches And Pain
FDA Label NDC 54291-054
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Canadian Custom Packaging Company for the product Zaxs Aches And Pain (NDC 54291-054). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache, Arthritis, Strains, Bruises, Sprains. Penetrating pain relief.
Dosage & Administration
For use by Adults and Children over 12 years of age: Apply a thin layer to affected area, not more than 4 times a day. Rub and massage into skin until solution vanishes. Always wash hands after applying. Store in airtight, light resistant container at room temperature.
Warnings
• For external use only.
•Allergy alert: If allergic to aspirin or salicylates, consult a physician before use.
•When using this product, use only as directed. Make sure you understand directions and warnings on label before use.
°Rare case of burns have been reported with products of this type.
°Do not apply with external heat (such as electric heating pad) or bandage tightly.
°Do not apply to wounds or damaged skin, or irritated skin.
°If you are allergic to any ingredient in this product, do not use. Avoid contact with eyes and mucous membranes.
•If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
•Stop use if: Redness is present, irritation develops, you experience pain, swelling or blistering where product is applied.
•Consult a physician if you are breastfeeding or pregnant before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, consult a Poison Control Centre immediately.
Inactive Ingredient
Aqua, Butyrospermum Parkii (Shea Butter) Extraxt, Caprylic/capric triglyceride, Caprylyl Glycol, Camphor, Carbomer copolymer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Eucalyptus Leaf Oil, Glycerin, Mentha piperita (Peppermint) oil, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Sorbic acid, Xanthan Gum
Package Label.Principal Display Panel
Tube Label
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