CLEANZE HAND SANITIZING- ethyl alcohol gel

CLEANZE HAND SANITIZING by

Drug Labeling and Warnings

CLEANZE HAND SANITIZING by is a Otc medication manufactured, distributed, or labeled by Skaffles Group Limited Liability Company, NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 71%

Purpose

Antiseptic

USE

For hand sanitizing to decrease 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

CLEANZE HAND SANITIZING 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77720-014
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: 77720-014-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
2	NDC: 77720-014-08	414 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
3	NDC: 77720-014-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
4	NDC: 77720-014-03	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
5	NDC: 77720-014-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
6	NDC: 77720-014-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
7	NDC: 77720-014-07	55 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
8	NDC: 77720-014-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
9	NDC: 77720-014-09	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020
10	NDC: 77720-014-10	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/10/2020

Labeler - Skaffles Group Limited Liability Company (831115642)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD		544493972	manufacture(77720-014)