OTC Medication Information: CLEANZE HAND SANITIZING

CLEANZE HAND SANITIZING- alcohol gel
Skaffles Group Limited Liability Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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).

CLEANZE HAND SANITIZING ethyl alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77720-016 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 71 mL in 100 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ALOE VERA LEAF WATER TROLAMINE ALPHA-TOCOPHEROL ACETATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:77720-016-01 500 mL in 1 BOTTLE None 2 NDC:77720-016-04 60 mL in 1 BOTTLE None 3 NDC:77720-016-03 237 mL in 1 BOTTLE None 4 NDC:77720-016-05 100 mL in 1 BOTTLE None 5 NDC:77720-016-02 1000 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/30/2020

Labeler — Skaffles Group Limited Liability Company (831115642)

Establishment
Name	Address	ID/FEI	Operations
Zhejiang Guoyao Jingyue Aerosol Co., Ltd.		554529812	manufacture (77720-016)

Revised: 01/2021 Skaffles Group Limited Liability Company