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.

INN (International Name):

BENZOCAINE

Composition:

BENZOCAINE 200 g in 1 mg

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 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

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 MAXIMUM TOOTHACHE 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
_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
FLAMMABLE: keep away from fire or flame. Avoid smoking during
application and until this product has
been dried
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 • _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 a day or ad 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 imprinted bottle seal is broken
or missing prior to opening • do not
continuously
_INACTIVE INGREDIENTS_ alcohol (54.5% by volume), flavor, polyehtylene
glycol, red 40, sodium saccarin,
water, yellow 5
Questions or comment? Call us at 800 952 5080 Mon thru Fri 9-5 or
visit our website at www orajel
com
#1
ORAL PAIN
RELIEVER BRAND
FOR TOOTHACHE
2X MORE
Active