Ocean Potion Suncare Ice Plus Pain Relieving Soothing Gel
FDA Label NDC 85638-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gnl Brands International, Llc for the product Ocean Potion Suncare Ice Plus Pain Relieving Soothing (NDC 85638-005). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 0.8% (as Lidocaine HCI)

Purpose

External Analgesic

Uses

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations

Warnings

For External Use Only

Stop Use And Ask A Doctor If

• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

• Children under 2 years of age: Ask a doctor.

Inactive Ingredients

aleurites moluccanus seed extract, allantoin, aloe barbadensis leaf juice, benzyl alcohol, blue 1, carbomer, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, disodium EDTA, fragrance, glycerin, laureth-23, mangifera indica (mango) fruit extract, menthol, menthyl lactate, passiflora incarnata flower extract, phenoxyethanol, plumeria acutifolia flower extract, polysorbate 20, propylene glycol, psidium guajava fruit extract, SD alcohol 40-B, tocopherol, tocopheryl acetate (vitamin e), triethanolamine, water.

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