HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fareva Morton Grove, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerin
3. FRAGRANCE (PARFUM)
   d. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
   e. BUTYLENE GLYCOL
   f. ALOE BARBADENSIS LEAF JUICE
   g. AMINOMETHYL PROPANOL
   h. 1,2-HEXANEDIOL
   i. AGAR
   j. GELLAN GUM
   k. CALCIUM ALGINATE
   l. PHENOXYETHANOL
   m. PROPYLENE GLYCOL
   n. PIGMENT RED 5 (CI 12490)
   o. CITRIC ACID
   p. SODIUM BENZOATE
   q. POTASSIUM SORBATE
   

Active Ingredient(s)

Alcohol 77% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

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 and redness develops and persists.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Agar, Aloe Barbadensis Leaf Juice, Alpha-Isomethyl Ionone,
Aminomethyl Propanol, Butylene Glycol, Calcium Alginate, Citric Acid, Fragrance (Parfum), Gellan Gum, Glycerin, Phenoxyethanol, Pigment Red 5 (Ci 12490, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water (Aqua)

Package Label - Principal Display Panel

50 mL NDC: 72686-186-05

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72686-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	77 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PIGMENT RED 5 (UNII: 91OZU993LX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALOE (UNII: V5VD430YW9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)
CALCIUM ALGINATE (UNII: 8P20S56HZI)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
AGAR (UNII: 89T13OHQ2B)
GLYCERIN (UNII: PDC6A3C0OX)
FRAGRANCE ORANGE ORC2000765 (UNII: GX5JI7UXQ7)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72686-186-05	50 mL in 1 TUBE; Type 0: Not a Combination Product	11/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/03/2020

Labeler - Fareva Morton Grove, Inc. (116752326)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Morton Grove, Inc.		116752326	manufacture(72686-186) , label(72686-186) , pack(72686-186) , relabel(72686-186) , repack(72686-186) , analysis(72686-186)