PROFESSIONAL - ADVANCED HAND SANITIZER- alcohol gel

Professional - Advanced Hand Sanitizer by

Drug Labeling and Warnings

Professional - Advanced Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

Ethyl Alcohol 71% v/v

Purpose

Antimicrobial

USES

Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

WARNINGS

• Flammable. Keep away from fire or flame.

• For external use only.

• When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

• Stop use and seek a doctor if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children. Children under 6 years of age should be supervised when using this product. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Put enough product in your palm to cover hands and rub hands together briskly until dry.

INACTIVE INGREDIENTS

Water (Aqua), Glycerin, Propanediol, Sodium Hyaluronate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Tocopherol, Carthamus Tinctorius Oleosomes, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Fragrance.

OTHER INFORMATION

Store at 68ºF to 77ºF (20ºC to 25ºC). May discolor fabrics.

SPL UNCLASSIFIED SECTION

Manufactured By: Professional Solutions
Boca Raton, FL 33487

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

Professional
Solutions®
PURE SCIENCE. BETTER SKIN

advanced hand
sanitizer gel

protect + moisturize

8 fl. oz. (240mL)

INGREDIENTS AND APPEARANCE

PROFESSIONAL - ADVANCED HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-1502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	0.71 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Propanediol (UNII: 5965N8W85T)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Tocopherol (UNII: R0ZB2556P8)
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)
Trolamine (UNII: 9O3K93S3TK)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-1502-0	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
2	NDC: 66163-1502-1	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
3	NDC: 66163-1502-2	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
4	NDC: 66163-1502-3	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
5	NDC: 66163-1502-4	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
6	NDC: 66163-1502-5	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
7	NDC: 66163-1502-6	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
8	NDC: 66163-1502-7	360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
9	NDC: 66163-1502-8	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

Labeler - Cosmetic Solutions LLC (807907928)