APOL HAND SANITIZER- alcohol gel 
ECOSEM CO., LTD

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.

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80082-201

Active ingredient

Ethanol 65%

Purpose

Antiseptic

Use

Hand clean sanitizer to help reduce bacteria on skin

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product

do not use in or near the eyes, ears and mouth. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and last.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

Other information

Store between 15-30C(59-86F)

Avoid freezing and excessive heat above 40C(104F)

Inactive ingredients

Water, Glycerin, Propylene glycol, Carbomer, Aloe Vera gel Triethanolamine, Cinnamomum Cassia Bark Extract, Camellia Sinensis Leaf Extract, Chamaecyparis Lawsoniana Wood Oil

Package Label

500ml NDC: 80082-201-01 Label

APOL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80082-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CHINESE CINNAMON (UNII: WS4CQ062KM)  
TROLAMINE (UNII: 9O3K93S3TK)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMAECYPARIS LAWSONIANA WOOD OIL (UNII: 0H3D02DVNU)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80082-201-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/19/2020
Labeler - ECOSEM CO., LTD (695632865)
Registrant - ECOSEM CO., LTD (695632865)
Establishment
NameAddressID/FEIBusiness Operations
ECOSEM CO., LTD695632865manufacture(80082-201)

Revised: 8/2020
Document Id: ac248267-03ce-2712-e053-2a95a90a8d71
Set id: ac248267-03cd-2712-e053-2a95a90a8d71
Version: 1
Effective Time: 20200805
 
ECOSEM CO., LTD