ORAL PAIN RELIEF- benzocaine and benzalkonium chloride gel

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

MAH:

Anicare Pharmaceuticals Pvt. Ltd

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

Oral pain reliever Antiseptic ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider ■ swelling, rash or fever develops ■ irritation, pain or redness persists or worsens ■ symptoms do not improve in 7 days

authorization_status:

OTC monograph not final

SPC

ORAL PAIN RELIEF- BENZOCAINE AND BENZALKONIUM CHLORIDE GEL
ANICARE PHARMACEUTICALS PVT. 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._
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ORAL PAIN RELIEF GEL
_ACTIVE INGREDIENTS_
Benzocaine 20%
Benzalkonium Chloride 0.1%
_PURPOSE_
Oral pain reliever
Antiseptic
_USE_
■ for the temporary relief of pain due to toothaches
■ to help protect against infection in minor oral irritation
_WARNINGS_
Methemoglobinemia warning: Use of this product may cause
methemoglobinemia, a serious condition
that must be treated promptly because it reduce the amount of oxygen
carried in blood. This can occur
even if you have used this product before. Stop use and seek immediate
medical attention if you or a
child in your care develops: pale, gray, or blue colored skin
(cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadness
• fatigue or lack of energy
_ALLERGY ALERT:_do not use this product if you have a history of
allergy to local anesthetics such as
procaine, butacaine or other "caine" anesthetics
DO NOT USE
■ more than directed
■ for more than 7 days unless directed by a physician or healthcare
provider
STOP USE AND ASK A PHYSICIAN IF
■ swelling, rash or fever develops
■ irritation, pain or redness persists or worsens
■ symptoms do not improve in 7 days
KEEP OUT OF REACH OF CHILDREN
In case of overdose or allergic reaction get medical help or contact a
Poison Control Center right
away.
_DIRECTIONS_
■ adults and children 2 years of age and over: apply a small amount
of the product to the cavity and
around the gum surrounding the teeth Use up to 4 times daily or as
directed by a physician or healthcare
provider
■ children under 12 years of age: should be supervised in the use of
this product
■ children under 2 years of age: Do not use
_OTHER INFORMATION_
■ this preparation is intended for use in cases