WALGREENS ANTIBACTERIAL HAND REFILL- benzalkonium chloride liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
WALGREEN COMPANY
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Helps eliminate bacteria on hands
Authorization status:
OTC monograph not final
Authorization number:
0363-7211-56

WALGREENS ANTIBACTERIAL HAND REFILL- benzalkonium chloride liquid

WALGREEN COMPANY

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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DRUG LABEL

Active ingredient

Benzalkonium Chloride 0.13%

Purpos e

Antibacterial

Us es

Helps eliminate bacteria on hands

Warnings

For external use only.

When using this product

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop use and ask doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

use to refill a hand soap pump bottle

from pump bottle, apply onto wet hands

lather and rinse thoroughly

Other informaton

store at room temperature

Inactive ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride,

Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium

EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035),

Yellow 5 (CI 19140), Red 33 (CI 17200)

Questions or comments?

1-800-925-4733

Label Copy

WALGREENS ANTIBACTERIAL HAND REFILL

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-7211

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CETRIMO NIUM CHLO RIDE (UNII: UC9 PE9 5IBP)

GLYCERIN (UNII: PDC6 A3C0 OX)

LAURAMIDO PRO PYLAMINE O XIDE (UNII: I6 KX16 0 QTV)

CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

PEG-12 0 METHYL GLUCO SE DIO LEATE (UNII: YM0 K6 4F20 V)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

WALGREEN COMPANY

EDETATE SO DIUM (UNII: MP1J8 420 LU)

SO DIUM SULFATE (UNII: 0 YPR6 5R21J)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 36 3-7211-

16 50 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/22/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 4/22/20 19

Labeler -

WALGREEN COMPANY (008965063)

Registrant -

APOLLO HEALT H AND BEAUT Y CARE INC. (201901209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

APOLLO HEALTH AND BEAUTY CARE INC.

20 19 0 120 9

ma nufa c ture (0 36 3-7211)

Revised: 4/2019

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