PROSANITIZE- benzalkonium chloride soap

Prosanitize by

Drug Labeling and Warnings

Prosanitize 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:

1. Benzalkonium chloride
2. Water(aqua),
3. sodium lauroyl sarcosinate,
4. sodium cocoyl isethionate,
5. cocamidopropyl betaine,
6. cocamidopropyl
7. PG-dimonium chloride phosphate,
8. glycerin, polyquaternium-7,
9. PEG-150 distearate,
10. phenoxyethanol,
11. sodium benzoate,
12. citric acid,
13. sodium chloride,
14. tetrasodium EDTA,
15. fragrance (parfum).

Active Ingredient(s)

Benzalkonium chloride 0.1% v/v. Purpose: Antibacterial

Purpose

Antibacterial

Use

Antibacterial soap to help reduce bacteria on skin that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame.

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 rash occurs. These may be signs of a serious condition.

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

Pump onto dry hands. Lather vigorously for at least 15 seconds, Rinse and dry thorougly.
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 lauroyl sarcosinate, sodium cocoyl isethionate, cocamidopropyl betaine, cocamidopropyl
PG-dimonium chloride phosphate, glycerin, polyquaternium-7, PEG-150 distearate, phenoxyethanol, sodium benzoate, citric acid, sodium chloride, tetrasodium EDTA, fragrance (parfum).

Package Label - Principal Display Panel

236 mL NDC: 76665-005-08

3785 mL NDC: 76665-005-01

INGREDIENTS AND APPEARANCE

PROSANITIZE 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76665-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)	0.4 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.2 mL  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.5 mL  in 100 mL
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	0.2 mL  in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	5 mL  in 100 mL
EDETATE SODIUM (UNII: MP1J8420LU)	0.05 mL  in 100 mL
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)	9.25 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.3 mL  in 100 mL
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)	6.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	75.5 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.1 mL  in 100 mL
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)	0.5 mL  in 100 mL
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)	1.2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76665-005-08	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/10/2020
2	NDC: 76665-005-01	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(76665-005)