H2ocean Nothing Liquid
FDA Label NDC 70411-104
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H2ocean, Llc for the product H2ocean Nothing (NDC 70411-104). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzalkonium Cl 0.13%
Lidocaine HCl 4%
Purpose
First aid antiseptic
Pain reliever
Uses
• first aid to help reduce the risk of infection in: • minor cuts • scrapes • burns
• first aid for the temporary relief of pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • rashes due to poison ivy
Warnings
For external use only.
Do not use • in the eyes or apply over large areas of the body • longer than 1 week unless directed by a doctor • in large quantities, particularly over raw surfaces or blistered areas
Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns
Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
• clean the affected area
• adults and children 2 years of age and older: apply a small amount of this product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first
• children under 2 years of age: do not use, consult a physician
Other Information
• this package is child-resistant
• store at room temperature
Inactive Ingredients
Aloe (Aloe barbadensis) Leaf Juice, Disodium EDTA, Poloxamer 407, Sea Salt, Water
Questions?
+1-772-219-8183
Packaging
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