PERSONAL CARE WET WIPES- 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:

Delta Brands & Products, LLC

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 0.1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic decreases bacteria on the skin if you are allergic to any of the ingredients irritation or rash develops and continues for more than 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

PERSONAL CARE WET WIPES- BENZALKONIUM CHLORIDE CLOTH
DELTA BRANDS & PRODUCTS, LLC
_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._
----------
DRUG FACTS
_ACTIVE INGREDIENT_
Benzalkonium Chloride 0.1%
_PURPOSE_
Antiseptic
_USES_
decreases bacteria on the skin
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
if you are allergic to any of the ingredients
WHEN USING THIS PRODUCT
do not get into eyes. If contact occurs, rinse thoroughly with water.
STOP USE AND ASK A DOCTOR IF
irritation or rash develops and continues for more than 72 hours
KEEP OUT OF REACH OF CHILDREN
If swallowed get medical help or contact a Poison Control Center right
away.
_DIRECTIONS_
adults and children 2 years and over ■ apply to hands
■ allow to dry without wiping.
children under 2 years ask a doctor before use.
_INACTIVE INGREDIENTS_
water, propylene glycol, cocamidopropyl betaine, PEG-7 glyceryl
cocoate, fragrance, PEG-40
hydrogenated castor oil, 2-bromo-2-nitropropane-1,3-diol, iodopropynyl
butacarbamate, disodium
EDTA, cetrimonium chloride, citric acid, tocopheryl acetate
PACKAGE LABEL
PERSONAL CARE WET WIPES
benzalkonium chloride cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:72133-434
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
0 .1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
Delta Brands & Products, LLC
WATER (UNII: 0 59 QF0 KO0 R)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)
PEG-7 GLYCERYL CO CO ATE (UNII: VNX7251543)
BRO NO PO L (UNII: 6 PU1E16 C9 W)
IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)
EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)
CETRIMO NIUM CHLO RIDE (UNII: UC9 PE9 5IBP)
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW