The following Structured Product Label (SPL) was submitted to the FDA by Ap Goldshield Llc for the product Goldshield 24 (NDC 40092-500). 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 description, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Description
- GOLDSHIELD 24 ALCOHOL FREE ANTIBACTERIAL HAND FOAM RINSE contains 0.1 % benzalkonium chloride antimicrobial agent, formulated with purified water, propylene glycol, methyl anthranilate and trihydroxysilylpropyldimethyloctadecyl ammonium chloride. Helps kill 99.99 % of germs and many common bacteria. Moisturizes and softens hands.
Otc - Active Ingredient
- Benzalkonium Chloride 0.1 % ------------------------------------ Antimicrobial
Otc - Purpose
Indications & Usage
- For hand washing to help reduce bacteria on the skin that could cause disease.
Warnings
- Caution: For External Use Only. Avoid contact with eyes. In case of contact flush with water. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours contact a physician.
Otc - Keep Out Of Reach Of Children
- Keep out of the Reach of Children. In case of accidental ingestion, get medical help or contact the Poison Control Center immediately.
Dosage & Administration
- Directions: Foam onto palm, massage into hands and fingernails and air dry. Children use with supervision.
Storage And Handling
- Store at room temperature not below 32 degrees F.
Inactive Ingredient
- Purified Water, Propylene Glycol, Methyl Anthranilate and Trihydroxysilylpropyldimethyloctadecyl Ammonium Chloride
Package Label.Principal Display Panel
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