ANTISEPTIC TOWELETTE- benzalkonium chloride swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

GFA Production (Xiamen) Co., Ltd.

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 0.13 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTISEPTIC TOWELETTE- BENZALKONIUM CHLORIDE SWAB
GFA PRODUCTION (XIAMEN) CO., LTD.
----------
DRUG FACTS
ACTIVE INGREDIENT:
Benzalkonium Chloride 0.13%
PURPOSE:
First Aid Antiseptic
USE:
For Professional and Hospital use. Helps prevent infection. Antiseptic
cleansing of face,
hands and body without soap and water.
WARNINGS:
For external use only.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away. If unusual
redness, swelling or other symptoms occur, consult a physician
immediately.
DO NOT USE:
In the eyes, or over large areas of the body.
DIRECTIONS:
Tear open packet, unfold towelette and use to cleanse desired skin
area. Discard
towelette appropriately after single use.
INACTIVE INGREDIENT:
Purified water.
PACKAGE LABELING:
ANTISEPTIC TOWELETTE
benzalkonium chloride swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:50814-002
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
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:50814-
002-01
1 in 1 BOX
03/22/2016
1
0.45 g in 1 POUCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
2
NDC:50814-
002-02
1 in 1 BOX
01/01/2019
2
0.25 g in 1 POUCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
GFA Production (Xiamen) Co., Ltd.
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M003
03/22/2016
LABELER -
GFA Production (Xiamen) Co., Ltd. (421256261)
Revised: 10/2023