Active Ingredients
Neem Oil 3%
Swimmers Itch Guard Oil
FDA Label NDC 63264-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Resolutions, Llc for the product Swimmers Itch Guard (NDC 63264-103). 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 ingredients, warnings, otc - stop use, otc - ask doctor, otc - keep out of reach of children, directions, other safety information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Topical Oil – for External Use Only
Keep out of eyes. Flush thoroughly and gently with warm water for 10-15 minutes.
Otc - Stop Use
Stop use and consult physician if rash or irritation develops.
Otc - Ask Doctor
Consult physician before using if pregnant or nursing.
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
(for children 2 years and older and adults): Apply sunscreen first, especially spray-on sunscreens which contain alcohol (alcohol removes our product). Before entering the water, apply Swimmer’s Itch Guard to all uncovered skin that will be under water continuously for 5 minutes or longer. Apply liberally and evenly. When coming out of the water, light toweling off is best because it minimizes removal of Swimmer’s Itch Guard. Reapply after 30 minutes of water activity, taking a shower or hot-tub, or repeated hard toweling offs. Wash swimsuits separately in warm water.
Other Safety Information
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
Inactive Ingredients
Fractionated Coconut Oil, Olive Oil, Avocado Oil, High Oleic Sunflower Oil, Cinnamon Oil, d-alpha Tocopherol (Vitamin E)
Indications & Usage
Swimmers itch oil
Otc - Purpose
Swimmers itch oil
* Please review the disclaimer below.
