BACTINE PAIN RELIEVING benzalkonium chloride and lidocaine hydrochloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bayer HealthCare LLC.

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 0.13 g in 100 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

BACTINE PAIN RELIEVING- BENZALKONIUM CHLORIDE AND LIDOCAINE
HYDROCHLORIDE LIQUID
BAYER HEALTHCARE 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._
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BACTINE PAIN RELIEVING CLEANSING SPRAY
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Benzalkonium Cl 0.13% w/w
First aid antiseptic
Lidocaine HCl 2.5% w/w
Pain relieving spray
US ES
first aid to help prevent bacterial contamination or skin infection,
and for temporary relief of pain and
itching associated with minor:
cuts
scrapes
burns
sunburn
skin irritations
WARNINGS
FOR EXTERNAL USE ONLY
ASK A DOCTOR BEFORE USE IF YOU HAVE
deep or puncture wounds
animal bites
serious burns
WHEN USING THIS PRODUCT
do not use in or near the eyes
do not apply over large areas of the body or in large quantities
do not apply over raw surfaces or blistered areas
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms persist for more than 7 days, or clear up and occur again
within a few days
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 older: clean the affected area; apply
a small amount on the area 1-3
times daily; may be covered with a sterile bandage (let dry first)
children under 2 years, ask a doctor
OTHER INFORMATION
®
OTHER INFORMATION
avoid excessive heat
INACTIVE INGREDIENTS
edetate disodium, fragrances, nonoxynol 9, propylene glycol, purified
water
QUES TIONS ?
1-800-986-0369 (Mon-Fri 9-5 EST) or www.bactine.com
PRINCIPAL DISPLAY PANEL - 150 ML BOTTLE LABEL
_BACTINE_
_SOOTHING INFECTION PROTECTION_
_PAIN RELIEVING _
_CLEANSING SPRAY_
_FIRST AID ANTISEPTIC / PAIN RELIEVER_
_Relieves Pain On Contact _
_Maximum Strength Antiseptic _
_to Kill Germs_
_NO STING_
To unlock, push in tab and twist right.
To lock, twist left until locked.
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BACTINE AND THE BACTINE LOGO
ARE REGISTERED TRADEMA