ATOREN PREMIUM HAND SANITIZER by Natuzen Co.,Ltd.

ATOREN PREMIUM HAND SANITIZER by

Drug Labeling and Warnings

ATOREN PREMIUM HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Natuzen Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ATOREN PREMIUM HAND SANITIZER- ethyl alcohol gel 
Natuzen 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

Ethyl alcohol 70%

INACTIVE INGREDIENT

Water, Butylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract

PURPOSE

Hand Sanitizer

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

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 Gel (60mL)

Package Label: Atoren Premium Hand Sanitizer Gel (1gal)

ATOREN PREMIUM HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70930-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70930-111-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	12/01/2021
2	NDC: 70930-111-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020	12/01/2021

Labeler - Natuzen Co.,Ltd. (688201272)

Registrant - Natuzen Co.,Ltd. (688201272)

Establishment
Name	Address	ID/FEI	Business Operations
Natuzen Co.,Ltd.		688201272	manufacture(70930-111)

Revised: 11/2022

Document Id: ab8ae411-7633-4a1e-94b1-91a924d9bc42

34390-5

Set id: bedeb574-8066-4ed6-aa95-bc90da39f83e

Version: 2

Effective Time: 20221114