HAND SANITIZER GEL- alcohol gel

HAND SANITIZER gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

alcohol 62%

INACTIVE INGREDIENT

Water
Butylene Glycol
Gallic Acid
Carbomer
Triethanolamine
PEG-60 Hydrogenated Castor Oil
Artemisia Vulgaris Extract
Rosmarinus Officinalis (Rosemary) Extract
Aloe Barbadensis Leaf Extract
Fragrance
Limonene

PURPOSE

hand and skin disinfection

WARNINGS

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children.

INDICATIONS & USAGE

apply enough of the product to the palm of your hand to wet your hands completely

rub your hands together, covering all surfaces, until they are dry

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58832-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GALLIC ACID (UNII: 632XD903SP)
ARTEMISIA VULGARIS TOP OIL (UNII: 72Q967Y48V)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58832-0003-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/04/2020
2	NDC: 58832-0003-2	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/04/2020

Labeler - EYESOME Co., Ltd. (557795360)

Registrant - EYESOME Co., Ltd. (557795360)

Establishment
Name	Address	ID/FEI	Business Operations
EYESOME Co., Ltd		557795360	manufacture(58832-0003)