ANTIBACTERIAL FOAMING HAND WASH- benzalkonium chloride soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

Sonchin Biomedical Cosmetics CORP.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic For handwashing to decrease bacteria on the skin Irritation or redness develops.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTIBACTERIAL FOAMING HAND WASH- BENZALKONIUM CHLORIDE SOAP
SONCHIN BIOMEDICAL COSMETICS CORP.
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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SONCHIN 023-01
ACTIVE INGREDIENT(S)
Benzalkonium Chloride (0.13%)
PURPOSE
Antiseptic
USE
For handwashing to decrease bacteria on the skin
WARNINGS
For external use only.
WEHN USING THIS PRODUCT
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with
water.
STOP USE AND ASK A DOCTOR IF
Irritation or redness develops.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Pump into wet hands.
Lather vigorously for at least 20 seconds.
Rinse & dry thoroughly.
Supervise children under 6 years of age when using this product to
avoid swallowing.
INACTIVE INGREDIENTS
Purified Water, Cocamidopropyl Betaine, Cocamide DEA, Decyl Glucoside,
Glycerin,
Lauryl/Myristyl Amidopropyl Amine Oxide, Polysorbate 20, Aloe
Barbadensis Leaf Juice,
Fragrance, Tetrasodium EDTA, Citric Acid,Methylchloroisothiazolinone,
Methylisothiazolinone.
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
260 mL NDC: 73662-021-01
ANTIBACTERIAL FOAMING HAND WASH
benzalkonium chloride soap
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73662-023
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
BENZ ALKONIUM
0.13 g
Sonchin Biomedical Cosmetics CORP.
UNII:7N6JUD5X6Y)
CHLORIDE
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LAUROYL/MYRISTOYL AMIDOPROPYL AMINE OXIDE (UNII: HY9O6ZW9CY)
POLYSORBATE 20