SANOTIS SANITIZER HAND by MEGACOS MANUFACTURING Co., Ltd.

SANOTIS SANITIZER HAND by

Drug Labeling and Warnings

SANOTIS SANITIZER HAND by is a Otc medication manufactured, distributed, or labeled by MEGACOS MANUFACTURING Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANOTIS SANITIZER HAND- alcohol gel 
MEGACOS MANUFACTURING Co., Ltd.

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ACTIVE INGREDIENT

Alcohol 70% w/w

INACTIVE INGREDIENT

Water, Allantoin, Panthenol, Glycerin, Carbomer, Aminomethyl Propanol

PURPOSE

Antiseptic

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Uses

Sanotis sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.

Directions

Place enough product on hands to cover all surface. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)
This product is intended only for sanitizing.
To prevent contents from drying out and contaminants from entering, close lid completely after use.
Keep product in its original container as storing the product in anything other than the original container may result in accidents or cause the integrity of the product to diminish.
Do not use over bandage, castings, etc. as irritation occur.

Other information

Store between 1-30℃ (33.8-86℉)
Avoid freezing and excessive heat above 40℃ (104℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SANOTIS SANITIZER HAND 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78063-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	210 g  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Allantoin (UNII: 344S277G0Z)
Panthenol (UNII: WV9CM0O67Z)
Glycerin (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AminomethylPropanol (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78063-030-01	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/01/2020	06/30/2020

Labeler - MEGACOS MANUFACTURING Co., Ltd. (694745986)

Registrant - MEGACOS MANUFACTURING Co., Ltd. (694745986)

Establishment
Name	Address	ID/FEI	Business Operations
MEGACOS MANUFACTURING Co., Ltd.		694745986	manufacture(78063-030)

Revised: 12/2023

Document Id: 8b175f8d-ff61-480a-922d-855e724e889e

34390-5

Set id: 26519e7b-d30f-4fd8-977f-f2c859413d4b

Version: 3

Effective Time: 20231205