NEO HAND SANITIZER- 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

Active ingredients: Ethyl alcohol 62%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-60 Hydrogenated Castor Oil, Triethanolamine, Panthenol, Tocopheryl Acetate,Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aloe Barbadensis Leaf Extract, Fragrance, Limonene, Citral

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

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.PRINCIPAL DISPLAY PANEL

Image of bottle

NEO HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70930-109
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	310 g in 500 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70930-109-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020	12/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/01/2020	12/01/2021

Labeler - Natuzen Co.,Ltd. (688201272)

Registrant - Natuzen Co.,Ltd. (688201272)

Name	Address	ID/FEI	Business Operations
Establishment
Natuzen Co.,Ltd.		688201272	manufacture(70930-109)

Revised: 11/2022

Document Id: 1c9545cd-52ff-43b3-bd28-0ebc4797edae

Set id: 3540d2ef-80a7-452d-b427-3cbeebd3c53c

Version: 2

Effective Time: 20221116

Natuzen Co.,Ltd.