BENZOCAINE- orajel severe toothache liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Church & Dwight Co., Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral Pain Reliever Use for the temporary relief of pain due to • canker sores • minor injury of the mouth and gum • minor irritation of the mouth and gums caused by dentures or orthodontic appliances Do not use • more than directed • for more than 7 days unless directed by a dentistor doctor •for teething •in children under 2 years of age 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

BENZOCAINE- ORAJEL SEVERE TOOTHACHE LIQUID
CHURCH & DWIGHT CO., INC.
_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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ORAJEL MEDICATED TOOTHACHE & GUM PAIN RELIEVER LIQUID
Benzocaine 20%
Menthol 0.1%
Oral Pain Reliever
_USE _for the temporary relief of pain due to • canker sores •
minor injury of the mouth and gum • minor
irritation of the mouth and gums caused by dentures or orthodontic
appliances
_WARNINGS_
METHEMOGLOBINEMIA WARNING: Use of this product may cuse
methemoglobinemia, a serious condition
that must be treated promptly becasue it reduces the amount of oxygen
carried in the 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 or breath • dizziness or lightheadedness •
fatigue or lack of engery
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
FLAMMABLE: keep away from fire or flame. Avoid smoking during
application.
DO NOT USE • more than directed • for more than 7 days unless
directed by a dentistor doctor •for
teething •in children under 2 years of age
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 • _remove imprinted safety seal from bottle cap
Adults and children 2 years of age and over
Apply product with cotton swab or finger to the affected area. Use up
to 4 times daily or as directed
by a dentist or doctor
Children under 12 years of age
Ask a doctor be