BENZOCAINE, MENTHOL, ZINC CHLORIDE- orajel severe pm toothache and gum relief cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Church & Dwight Co., Inc.

INN (International Name):

BENZOCAINE

Composition:

BENZOCAINE 200 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Use • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums 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 • allergic reaction occurs Use • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

Authorization status:

OTC monograph not final

Summary of Product characteristics

BENZOCAINE, MENTHOL, ZINC CHLORIDE- ORAJEL SEVERE PM TOOTHACHE AND GUM
RELIEF CREAM
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._
----------
ORAJEL SEVERE PM TOOTHACHE & GUM RELIEF
Benzocaine 20%
Menthol 0.25%
Zinc Chloride 0.15%
_USE_ • for the temporary relief of oral pain due to minor
irritation or injury of the mouth and gums
_WARNINGS_
• 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 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 • allergic reaction
occurs
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_ • cut open tip of tube on score mark
Adults and children 2 years of age and over - Apply a small amount of
product to the affected area, 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 - Ask a physician or healthcare provider
_OTHER INFORMATION • _do not use if tube tip is cut prior to opening
• do not use continuously • Cream will
stay in place for extended duration of relief.
cellulose gum, chamomile, gelatin, methyl salicylate, mineral oil,
pectin, petrolatum, polyethylene
glycol, sodium saccharin
_QUESTION OR COMMENTS _call us at 800 952 5080 Monday through Friday
9-5 or visit www orajel com
_USE_ • for the temporary relief of oral pain due to minor
irritation or injury of the mouth and gums
#1
Oral Pain
Reliever Brand
For Toothache