FUNDAMENTALS- benzalkonium chloride soap 
Clean Beauty Concepts

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.

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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.

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.

Directions

• Wet hands, apply palmful to hands, scrub thoroughly, rinse thoroughly

Other information

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: 76665-015-08

Fresh 8oz

60 mL NDC: 76665-015-02

2 oz473 mL NDC: 76665-015-16

16 oz 3785mL NDC: 76665-015-01

1 Gal

FUNDAMENTALS 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76665-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CLEAN ORC0600327 (UNII: 329LCV5BTF) 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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76665-015-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/10/2020
2NDC:76665-015-013785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/10/2020
3NDC:76665-015-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/10/2020
4NDC:76665-015-16473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/10/2020
Labeler - Clean Beauty Concepts (117491649)
Establishment
NameAddressID/FEIBusiness Operations
Clean Beauty Concepts117491649manufacture(76665-015)

Revised: 10/2020
Document Id: b1d17734-7364-9828-e053-2995a90a4b91
Set id: b0e09a04-86cd-1529-e053-2995a90ab2ac
Version: 2
Effective Time: 20201016
 
Clean Beauty Concepts