LUCKY ANTIBACTERIAL- benzalkonium chloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Delta Brands, Inc

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 0.13 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial for hand washing to decrease bacteria on the skin ■ irritation and redness develops

Authorization status:

OTC monograph not final

Summary of Product characteristics

LUCKY ANTIBACTERIAL- BENZALKONIUM CHLORIDE LIQUID
DELTA BRANDS, INC
_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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LUCKYLVNDRPRPLEBKC013
_ACTIVE INGREDIENT_
Benzalkonium Chloride 0.13%
_PURPOSE_
Antibacterial
_USES_
for hand washing to decrease bacteria on the skin
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
■ avoid contact with the eyes. In case of eye contact, flush with
water.
STOP USE AND ASK A DOCTOR IF
■ irritation and redness develops
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
■ pump into hands, wet as needed ■ lather vigorously for at least
15 seconds ■ wash
skin, rinse thoroughly and dry
_INACTIVE INGREDIENTS_
water, cocamidopropyl betaine, cetrimonium chloride, coco-glucoside,
glyceryl oleate,
cocamide MEA, glycerin, PEG-150 distearate, sodium chloride,
fragrance, citric acid,
methylchloroisothiazolinone, methylisothiazolinone, FDC blue no. 1, DC
red no. 33
PACKAGE LABEL
LUCKY ANTIBACTERIAL
benzalkonium chloride liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:20276-144
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.13 g
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Delta Brands, Inc
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1