4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- benzocaine gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Available from:

Rite Aid

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Use * for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation Warnings Methemoglobinemia warning: use of this product ay cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in teh 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 lightneadedness * fatigue or lack of energy do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsen

Authorization status:

OTC monograph not final

Summary of Product characteristics

4X MEDICATED SEVERE TOOTHACHE AND GUM GEL- BENZOCAINE GEL
RITE AID
_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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Active Ingredients Purpose
Benzalkonium Chloride 0.13% .... Oral Antiseptic
Benzocaine 20% ......................... Oral Pain Reliever
Menthol 0.5% .............................. Oral Pain Reliever
Zinc Chloride 0.15% .................... Oral Astringent
USE
Use * for the temporary relief of pain due to toothaches * to help
protect against
infection of minor oral irritation
Warnings
Methemoglobinemia warning: use of this product ay cause
methemoglobinemia, a
serious condition that must be treated promptly because it reduces the
amount of
oxygen carried in teh 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 lightneadedness * 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, benzocaine or other "caine" anesthetics
Do not use * more than directed * for more than 7 days unless told to
do so by a
dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops *
irritation, pain or
redness persists or worsens * symptoms do not improve in 7 days *
allergic reaction
occurs
Keep out of reach of children. In case of overdose, get medical help
or contact a Poison
Control Center right away.
DIRECTIONS
* cut open tip of tube to score mark * adults and children 2 years of
age and older:
apply a small amount of product to teh cavity and around the gum
surrounding the
teeth. Use up to 4 times daily or as directed by a dentist or doctor *
children under 12
years of age sh