The following Structured Product Label (SPL) was submitted to the FDA by Clean Beauty Concepts for the product Fundamentals (NDC 76665-015). 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 other, active ingredient(s), purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
The hand soap is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:
Benzalkonium chloride
Water(aqua)
Sodium alpha olefin sulfonate
Cocamide DIPA
Cocamidopropyl betaine
Glycerin
Polyquaternium-7
Phenoxyethanol
Aloe barbadensis (aloe vera) leaf juice
Sodium benzoate
Citric acid
Sodium chloride
Tetrasodium EDTA
Fragrance (parfum)
Benzalkonium chloride 0.13% v/v. Purpose: Antibacterial
Antibacterial
For handwashing to decrease bacteria on skin
Recommended for repeat use
For external use only.
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if
irritation or redness develop
Condition persists more than 72 hours
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• Wet hands, apply palmful to hands, scrub thoroughly, rinse thoroughly
Water(aqua)
Sodium alpha olefin sulfonate
Cocamide DIPA
Cocamidopropyl betaine
Glycerin
Polyquaternium-7
Phenoxyethanol
Aloe barbadensis (aloe vera) leaf juice
Sodium benzoate
Citric acid
Sodium chloride
Tetrasodium EDTA
Fragrance (parfum)
236 mL NDC: 76665-015-08
* Please review the disclaimer below.
