Black Fly Guard
FDA Label NDC 63264-201

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 Black Fly Guard (NDC 63264-201). 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, other ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

NEEM OIL 3%

Warnings

TOPICAL OIL - 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.

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). IF A SPRAY-ON SUNSCREEN IS REAPPLIED, THEN OUR PRODUCT MUST BE REAPPLIED TOO.

Other Ingredients

FRACTIONATED COCONUT OIL, OLIVE OIL, AVOCADO OIL, HIGH OLEIC SAFFLOWER OIL, CINNAMOM OIL, D-ALPHA TOCOPHEROL (VITAMIN E).

* Please review the disclaimer below.