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

Stop use and ask a doctor if irritation and redness develops and persists.

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

SunnyOrange

HAND SANITIZER
alcohol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Fareva Morton Grove, Inc. (116752326)

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