Otc - Active Ingredient
Lidocaine 4%
Swiftalyn Numbing Cream
FDA Label NDC 87013-002
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 87013-002). 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, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For temporary relief of minor pain, burning and soreness.
Indications & Usage
For use as a local anesthetic to numb the skin prior to minor medical or cosmetic procedures
Warnings
For external use only
Otc - When Using
■ avoid contact with eyes or mucous membranes ■ Use only as directed ■ do not put this product into the rectum by using fingers or any mechanical device or applicator
Otc - Stop Use
■ condition worsens or does not improve within 7 days ■ rectal bleeding occurs ■ 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
Otc - Keep Out Of Reach Of Children
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
Purified Water, Propylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Lecithin, Polysorbate 80, Aloe Vera Leaf Juice, Carbomer, Triethanolamine, Tocopheryl Acetate, Allantoin, Menthol, Phenoxyethanol, Ethylhexylglycerin.
Otc - Questions
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Package Label.Principal Display Panel
2321 (546789package)
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