PROFESSIONAL SOLUTIONS - HAND SANITIZER FOAM- benzalkonium chloride liquid 
Cosmetic Solutions LLC

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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Professional Solutions® - Hand Sanitizer Foam

DRUG FACTS:

ACTIVE INGREDIENTS

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

USES

To decrease bacteria on the skin

WARNINGS

For external use only: Hands only

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid contact with broken skin.

Stop use and seek a doctor if redness or irritation develops and persist for 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 thoroughly with product and allow to dry without wiping - for children under 6, use only under adult supervision - not recommended for infants.

INACTIVE INGREDIENTS

Water (Aqua), Propanediol, Glycereth-7 Triacetate, Glycerin, Babassu Oil Glycereth-8 Esters, Decyl Glucoside, Calendula Officinalis Flower Extract, Equisetum Arvense Extract, Geranium Maculatum Extract, Honey, Citric Acid, Panax Ginseng Root Extract, Salvia Officinalis Leaf Extract, Sambucus Nigra Flower Extract, Ethylhexylglycerin, Phenoxyethanol, Sodium Hydroxide.

Manufactured By: Professional Solutions
Boca Raton, FL 33487

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

Professional
Solutions®
PURE SCIENCE. BETTER SKIN

hand sanitizer
foam

protect + moisturize

1.7 fl. oz. (50mL)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
PROFESSIONAL SOLUTIONS - HAND SANITIZER FOAM 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-1900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propanediol (UNII: 5965N8W85T)  
Glycereth-7 Triacetate (UNII: S9W6Z48HUP)  
Glycerin (UNII: PDC6A3C0OX)  
Babassu Oil Glycereth-8 Esters (UNII: 12XQ76K0YL)  
Decyl Glucoside (UNII: Z17H97EA6Y)  
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
Equisetum Arvense Branch (UNII: 1L0VKZ185E)  
Geranium Maculatum Root (UNII: 93IXI5B6OJ)  
Honey (UNII: Y9H1V576FH)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Asian Ginseng (UNII: CUQ3A77YXI)  
Sambucus Nigra Flower (UNII: 07V4DX094T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-1900-050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
2NDC:66163-1900-1120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E05/01/2020
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 7/2020
Document Id: 3711c729-8d95-4afe-8bb3-13bdee33cf8d
Set id: b8cfe175-43bd-49aa-a407-2191303605a7
Version: 1
Effective Time: 20200714
 
Cosmetic Solutions LLC