Swimmers Itch Guard
FDA Label NDC 63264-102

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 63264-102). 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, otc - keep out of reach of children, directions (for children 2 years and older and adults):, other ingredients:, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

EUCALYPTUS OIL 20%

Purpose

SKIN PROTECTANT

Uses

  • PREVENT SWIMMER'S ITCH
  • SAFE FOR CHILDREN
  • LONG LASTING PROTECTION

Warnings

TOPICAL CREAM - FOR EXTERNAL USE ONLY - KEEP OUT OF EYES. FLUSH THOROUGHLY AND GENTLY WITH WARM WATER FOR 10-15 MINUTES. STOP USE AND CONSULT PHYSICIAN IF RASH OR IRRITATION DEVELOPS. 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 60 minutes of water activity, taking a shower or hot-tub, or repeated hard toweling offs. Wash swimsuits separately in warm water.

Other Ingredients:

Fractionated Coconut Oil, Olive Oil, Avocado Oil, High Oleic Safflower Oil, Cinnamon Oil, d-alpha Tocopherol (Vitamin E).

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