PRIME-GEL- benzocaine gel

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Disponibbli minn:

Prime Dental Manufacturing, Inc.

Rotta amministrattiva:

PERIODONTAL

Tip ta 'preskrizzjoni:

OTC DRUG

Indikazzjonijiet terapewtiċi:

Use: for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures. Indications/Directions: Apply only amount needed to the oral mucosa to prevent or relieve pain. See drug facts. Purpose: Oral Anesthetic. See drug facts.

L-istatus ta 'awtorizzazzjoni:

OTC monograph not final

Karatteristiċi tal-prodott

PRIME-GEL- BENZOCAINE GEL
PRIME DENTAL MANUFACTURING, 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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Use for Oral mucosal use only, as directed by dentist. For the
temporary relief of pain
due to minor dental procedures.
Do not use for more than 7 days unless directed by a dentist or
doctor.
See drug facts.
LIST OF INACTIVE INGREDIENTS
Flavoring, PEG3350, PEG400, sodium saccharin, water. may contain
blue#, green #5,
red #3, red #28, red#40, yellow #5 as color additives.
Use: for Oral mucosal use only, as directed by dentist. For the
temporary relief of pain
due to minor dental procedures.
Indications/Directions: Apply only amount needed to the oral mucosa to
prevent or
relieve pain.
See drug facts.
Keep out of reach section.
See drug facts:
Purpose: Oral Anesthetic.
See drug facts.
Active Ingridient: Benzocaine 0.2 g (200mg) per gram.
See drug facts.
Warnings
Allergy Alert: Do not use on patients with a history of allergies to
local anesthetics such
as benzocaine or other "caine" anesthetics.
Do not use for more than 7 days unless directed by a dentist or
doctor. if sore mouth
symptoms do not improve in 7 days; irritation, pain, or redness
persists or worsens; or
if swelling, rash or fever develops, see your dentist or doctor
promptly.
When using this product avoid contact with eyes. If contact occures,
flush with water.
Stop use and consult a health care practitioner if the following
symptoms appear:
weakness, confusion, headache, difficulty breathing, and/or pale, grey
or blue colored
skin, as these may be signs of methemoglobinemia, a rare disorder,
which may appear
up to 2 hours after use.
Do not exceed recommended dosage. If more than used for pain is
accidentally
swaloowed, get medical help or contact a posion control center
immediately.
If pregnant or breast feeding, ask a health care proffesional before
use.
Keep out of reach of