Otc - Active Ingredient
Menthol 1%
Swiftalyn Numbing Cream
FDA Label NDC 87013-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genuine Innovation Ltd for the product Swiftalyn Numbing Cream (NDC 87013-003). 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, warnings, dosage & administration, other safety information, inactive ingredient, otc - questions, 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
Temporary relief of minor aches and pains of muscles and joints
Warnings
For external use only ■ avoid contact with eyes or mucous membranes ■ Use only as directed ■ condition worsens or does not improve within 7 days ■ allergic reaction occurs to ingredients in this product ■ symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
■ Adults: When practical, clean and dry the affected area. Apply externally to the affected area up to 3 times daily. ■ Children under 12 years of age: consult a doctor.
Other Safety Information
■ Store at room temperature 15–30°C (59–86°F) ■ Keep away from direct sunlight or heat
Inactive Ingredient
Water, Propylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Lecithin, Polysorbate 80, Aloe Vera Leaf Juice, Carbomer, Triethanolamine, Tocopheryl Acetate, Allantoin, Menthol, Phenoxyethanol, Ethylhexylglycerin.
Otc - Questions
Email at: [email protected]
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Package Label.Principal Display Panel
1 (Label)
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