ANTIBACTERIAL WIPES- benzalkonium chloride, didecyldimonium chloride cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA), BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

Shandong mengyida daily necessities Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic ANTIBACTERIAL WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTIBACTERIAL WIPES- BENZALKONIUM CHLORIDE, DIDECYLDIMONIUM CHLORIDE
CLOTH
SHANDONG MENGYIDA DAILY NECESSITIES CO., LTD.
_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._
----------
ANTIBACTERIAL WIPES
ACTIVE INGREDIENT(S)
Benzalkonium chlorid 0.1%, Didecyldimonium Chloride 2%, Purpose:
Antiseptic
PURPOS E
Antiseptic
US E
ANTIBACTERIAL WIPES to help reduce bacteria that potentially can cause
disease. For use when
soap and water are not available.
WARNINGS
For external use only. Flammable. Keep away from heat or flame
DO NOT USE
in children less than 2 months of age
on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of
contact with eyes, rinse eyes
thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be
signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
Stop use and ask a doctor if irritation or rash occurs. These may be
signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
wipe the body skin or other surface..
Supervise children under 6 years of age when using this product to
avoid swallowing.
OTHER INFORMATION
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENTS
purified water USP
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
ANTIBACTERIAL WIPES
benzalkonium chloride, didecyldimonium chloride cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:9 0 0 42-20 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIDECYLDIMO NIUM CHLO RIDE (UNII: JXN40 O9 Y9 B) (DIDECYLDIMONIUM -
UNII:Z7F472XQPA)
DIDECYLDIMONIUM
CHLORIDE
0 .2
in 10 0
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKO