FDA Label for Fundamentals
View Indications, Usage & Precautions
Fundamentals Product Label
The following document was submitted to the FDA by the labeler of this product Clean Beauty Concepts. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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)
Active Ingredient(S)
Benzalkonium chloride 0.13% v/v. Purpose: Antibacterial
Purpose
Antibacterial
Use
For handwashing to decrease bacteria on skin
Recommended for repeat use
Warnings
For external use only.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if
irritation or redness develop
Condition persists more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Wet hands, apply palmful to hands, scrub thoroughly, rinse thoroughly
- Supervise children under 6 years of age when using this product to avoid swallowing
Other Information
- Store between 15-30°C (59-86°F) .
• Avoid freezing and excessive heat above 40°C (104°F).
Inactive Ingredients
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)
Package Label - Principal Display Panel
236 mL NDC: 76665-010 -08
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