Label: FUNDAMENTALS- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 76665-017-01, 76665-017-02, 76665-017-08, 76665-017-16 - Packager: Clean Beauty Concepts
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 16, 2020
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
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)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
FUNDAMENTALS
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76665-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mg in 100 mL Inactive Ingredients Ingredient Name Strength POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) 0.35 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 mL in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.15 mL in 100 mL FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5) 0.1 mL in 100 mL WATER (UNII: 059QF0KO0R) 75.71 mL in 100 mL COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 3.42 mL in 100 mL EDETATE SODIUM (UNII: MP1J8420LU) 0.01 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.35 mL in 100 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.1 mL in 100 mL DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W) 8.47 mL in 100 mL ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) 0.1 mL in 100 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.02 mL in 100 mL SODIUM C12 OLEFIN SULFONATE (UNII: K7QRZ05DE3) 10.79 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76665-017-08 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/10/2020 2 NDC:76665-017-16 473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/10/2020 3 NDC:76665-017-02 60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/10/2020 4 NDC:76665-017-01 3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/10/2020 Labeler - Clean Beauty Concepts (117491649) Establishment Name Address ID/FEI Business Operations Clean Beauty Concepts 117491649 manufacture(76665-017)
3785mL NDC: 76665-017-01
