FUNDAMENTALS- benzalkonium chloride soap

Fundamentals by

Drug Labeling and Warnings

Fundamentals by is a Otc medication manufactured, distributed, or labeled by Clean Beauty Concepts. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if

irritation or redness develop

Condition persists more than 72 hours

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: 76665-016-08

473 mL NDC: 76665-016-16

60 mL NDC: 76665-016-02

3785mL NDC: 76665-016-01

INGREDIENTS AND APPEARANCE

FUNDAMENTALS 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76665-016
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 LEMON ORC2001060 (UNII: K1725A7G95)	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: 76665-016-08	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/10/2020
2	NDC: 76665-016-16	473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/10/2020
3	NDC: 76665-016-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/10/2020
4	NDC: 76665-016-01	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(76665-016)