ATOREN PREMIUM HAND SANITIZER- alcohol gel 
Kcommerce 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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ACTIVE INGREDIENT

Active ingredients: Ethyl alcohol 70% v/v

INACTIVE INGREDIENT

Inactive ingredients:

Aloe Barbadensis Gel, Carbomer, FD &C Blue No.1,FD &C Yellow No.5, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate,
Propylene Glycol, Tocopheryl Acetate, Water.

PURPOSE

Purpose: Hand Sanitizer

WARNINGS

Warnings:

• Flammable. Keep away from fire or flame.
• For external use only.
• When using this product do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.
• Stop use and ask a doctor if irritation or rash appears and lasts.
• Keep Out of Reach of Children.
• Do not eat.
• If swallowed, get medical help or contact a Poison Control
Center right away

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:
Hand sanitizer to help reduce bacteria on the skin

Directions

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. Not recommended for infants.

PACKAGE LABEL - ATOREN PREMIUM HAND SANITIZER 50mL

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PACKAGE LABEL - ATOREN PREMIUM HAND SANITIZER 500mL

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ATOREN PREMIUM HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74775-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74775-010-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
2NDC:74775-010-02500 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2020
Labeler - Kcommerce Co.,Ltd (689860484)
Registrant - Kcommerce Co.,Ltd (689860484)
Establishment
NameAddressID/FEIBusiness Operations
Natuzen Co.,Ltd.688201272manufacture(74775-010)

Revised: 4/2020
Document Id: de4e05b5-eaeb-4fe9-b856-4f884fd4e21c
Set id: 833efe81-3b9d-44d6-ae09-44912b3f8813
Version: 1
Effective Time: 20200413
 
Kcommerce Co.,Ltd