ORAJEL 3X MEDICATED FOR DENTURE PAIN- benzocaine, menthol, zinc chloride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A), ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Church & Dwight Co., Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Benzocaine - Oral Pain Reliever Menthol - Oral Pain Reliever Zinc Chloride - Oral Astringent Use for the temporary relief of • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth Do not use • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age Stop use and ask a doctor if • symptoms do not improve in 7 days • swelling, rash or fever develops • irritation, pain or redness persists or worsens

Authorization status:

OTC monograph not final

Summary of Product characteristics

ORAJEL 3X MEDICATED FOR DENTURE PAIN- BENZOCAINE, MENTHOL, ZINC
CHLORIDE GEL
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 3X MEDICATED FOR DENTURE PAIN - INSTANT PAIN RELIEF GEL
Benzocaine 20%
Menthol 0.5%
Zinc Chloride 0.15%
Benzocaine - Oral Pain Reliever
Menthol - Oral Pain Reliever
Zinc Chloride - Oral Astringent
Use for the temporary relief of • pain due to minor irritation of
the mouth and gums
caused by dentures • occasional minor irritation, pain, sore mouth
METHEMOGLOBINEMIA WARNING: Use of this product may cause
methemoglobinemia, a
serious condition that must be treated promptly because 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
heartrate • shortness of
breath • dizziness or lightheadedness • 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
directed by a dentist
or doctor • for teething • in children under 2 years of age
STOP USE AND ASK A DOCTOR IF • symptoms do not improve in 7 days •
swelling, rash
or fever develops • irritation, pain or redness persists or worsens
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 thin layer to the affected area. Do not reinsert dental work
until
irritation/pain is relieved. Rinse out well before reinserting. Apply
to
affected area up to 4 times daily or as directed