MEDICHOICE OB CLEANSING- benzalkonium chloride cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Owens & Minor Distribution, Inc.

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 0.13 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First aid antiseptic product to apply topically to the skin to help prevent infection in minor cuts, scrapes, and burns.

Authorization status:

OTC monograph not final

Summary of Product characteristics

MEDICHOICE OB CLEANSING- BENZALKONIUM CHLORIDE CLOTH
OWENS & MINOR DISTRIBUTION, INC.
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MEDICHOICE OB CLEANSING TOWELETTE
_DRUG FACTS_
_ACTIVE INGREDIENT_
Benzalkonium Chloride, 0.13% w/w
_PURPOSE_
First Aid Antiseptic
_USE_
First aid antiseptic product to apply topically to the skin to help
prevent infection in minor
cuts, scrapes, and burns.
_WARNINGS_
FOR EXTERNAL USE ONLY. DO NOT INSERT INTO THE VAGINA.
DO NOT USE
in the eyes or apply over large areas of the body.
longer than 1 week unless directed by a doctor.
no infants. CONSULT A DOCTOR
in case of deep or punture wounds, animal bites, or serious burns.
STOP USE AND CONSULT A DOCTOR
If the condition persists or gets worse.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison control Center
right away.
_DIRECTIONS_
Clean the affected area 1 to 3 times daily or as directed by a doctor.
May be covered
with a sterile bandage when dry.
_OTHER INFORMATION_
Store at room temperature.
Allow pad to air dry before disposal.
_INACTIVE INGREDIENT_
Isopropyl Alcohol, Purified Water, Thyme Camphor
PACKAGE LABELING:
MEDICHOICE OB CLEANSING
benzalkonium chloride cloth
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:39892-0306
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 g
Owens & Minor Distribution, Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
THYMOL (UNII: 3J50XA376E)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:39892-
0306-1
10 in 1 CASE
08/29/2017
1
100 in 1 BOX
1
1 in 1 PACKET
1
0.75 g in 1 PATCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M003
08/29/2017
LABELER -
O