HAND SANITIZER- ethyl alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Skaffles Group Limited Liability Company, Zhejiang Guoyao Jingyue Aerosol Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 71%

Purpose

Antiseptic

USE

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

Warning

For external use only. Flammable. Keep away from fire or flame. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Discontinue use if irritation and redness develop. lf condition persists for more than 72 hours consult a physician.

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

Directions

Directions . Pump a small amount in your palm and briskly rub hands together until dry.
Children under 6 years of age should be supervised when in use. Other information . Store between 15 and 30C(59 and 86F).· Avoid freezing and excessive heat above 40C(104F).

Inactive ingredients

Aloe Barbadensis Leaf Extract, Carbomer,Glycerin,Tocopheryl Acetate (Vitamin E), Triethanolamine, Water(Aqua).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77720-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77720-012-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
2	NDC: 77720-012-08	340 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
3	NDC: 77720-012-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
4	NDC: 77720-012-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
5	NDC: 77720-012-05	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
6	NDC: 77720-012-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
7	NDC: 77720-012-07	75 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
8	NDC: 77720-012-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
9	NDC: 77720-012-09	170 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020
10	NDC: 77720-012-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/15/2020

Labeler - Skaffles Group Limited Liability Company (831115642)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Guoyao Jingyue Aerosol Co., Ltd.		554529812	manufacture(77720-012)