Hunter Beach 4% Gel
FDA Label NDC 82517-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hunters Beach Life for the product Hunter Beach 4% (NDC 82517-002). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine 4%
Purpose
Topical Anesthetic
Uses
• Temporary relief of pain and itching
• Helps relieve and soothes pain from sunburn, minor burns, skin irritations, scrapes, insect bites
Warnings
For external use only.
Do not use in large quantities, particularly over raw surfaces or areas with blisters.
When using this product avoid contact with eyes. Use only as directed. Intentional misuse by deliberate concentrating and inhaling the contents can be harmful or fatal.
Stop use and consult a doctor if condition worsens, or symptoms last more than 7 days. Symptoms clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away
Directions
• Adults and children 2 years or older: apply to affected area not more than 3-4 times daily
• Children under 2 years of age: do not use, ask a doctor.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Glycerin, Triethanolamine, Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, DMDM Hydantoin, Fragrance, FD&C Blue #1.
Packaging
Gel (82517 002 05)
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