ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM- benzalkonium chloride, benzocaine, menthol, zinc chloride gel

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Vedd Meg Most

Letöltés Termékjellemzők (SPC)
10-01-2023

Aktív összetevők:

Belzalkonium chloride 0.13%, Benzocaine 20%, Menthol 0.5%, Zinc chloride 0.15%

Beszerezhető a:

Church & Dwight Co., Inc.

Az alkalmazás módja:

TOPICAL

Recept típusa:

OTC DRUG

Terápiás javallatok:

Oral antiseptic, Oral pain reliever, Oral astringent - for the temporary relief of pain due to minor irritation or injury of the mouth and gums - first aid to help prevent infection in minor oral irritation - more than directed - for more than 7 days unless directed by a dentist or doctor - for teething - in children under 2 years of age - symptoms do not improve in 7 days - swelling, rash or fever develops - irritation, pain or redness persists or worsens

Engedélyezési státusz:

OTC monograph not final

Termékjellemzők

                                ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM- BENZALKONIUM CHLORIDE,
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._
----------
ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM, GEL
ACTIVE INGREDIENTS
Belzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.5%
Zinc chloride 0.15%
PURPOSE
Oral antiseptic, Oral pain reliever, Oral astringent
USE
for the temporary relief of pain due to minor irritation or injury of
the mouth and
gums
first aid to help prevent infection in minor oral irritation
WARNINGS
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 heart
rate, 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 to affected area up to 4 times daily or as directed by a dentist
or doctor
Children between 2 and 12 years of age
Ask a doctor before use. Should be supervised in the use of this
product
Children under 2 years
                                
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