1. Home
  2. Labeler Index
  3. Gnl Brands International, Llc
  4. 85638-005
  5. Label Information: Ocean Potion Suncare Ice Plus Pain Relieving Soothing

FDA Label for Ocean Potion Suncare Ice Plus Pain Relieving Soothing

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. LABEL

Ocean Potion Suncare Ice Plus Pain Relieving Soothing Product Label

The following document was submitted to the FDA by the labeler of this product Gnl Brands International, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


* Please review the disclaimer below.