BENOA ACM HAND SANITISER- alcohol gel

Benoa ACM Hand Sanitiser by

Drug Labeling and Warnings

Benoa ACM Hand Sanitiser by is a Otc medication manufactured, distributed, or labeled by Natuzen Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl alcohol

INACTIVE INGREDIENT

Water, carbomer, Triethanolamine, glycerin, propylene glycol, panthenol, dipotassium glycyrrhizate, aloe barbadensis leaf juice, sodium hyaluronate, tocopheryl acetate

PURPOSE

instant health care personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin

WARNINGS

For external use only when using this product
If the following abnormal symptoms persist, discontinue use irritation around the eyes, ears,
mucous membranes, including the mouth, irritation or rashes on the skin.
Stop use immediately and consult a doctor if you experience the following :
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin irritation
3) Follow instructions when using medication.
(1) For external use only (Do not use internally)
(2) Avoid getting into the eyes (If contact occurs, rinse thoroughly with clean water)
Be careful not to inhale or use for extended periods of time (inhalation of ethanol
repeatedly can cause irritation to mucous membranes and headaches or other symptoms
may appear. When used repeatedly on the same area, skin irritation may occur.
Do not use the product on the same areas for extended periods of time as swelling,
inflammation or sickness may occur due to absorption through the skin.
It is not recommended to use on areas with open wounds 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

Pour a small amount into hands, spread evenly and rub into the skin.

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENOA ACM HAND SANITISER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70930-202
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
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70930-202-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/04/2020
2	NDC: 70930-202-02	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/04/2020
3	NDC: 70930-202-03	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2020

Labeler - Natuzen Co.,Ltd. (688201272)

Registrant - Natuzen Co.,Ltd. (688201272)

Establishment
Name	Address	ID/FEI	Business Operations
Natuzen Co.,Ltd.		688201272	manufacture(70930-202)