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Primo Topical Anesthetic by Tri State Dental

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g
Labeler: Tri State Dental
NDC Code: 69509-007

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.

Active Ingredients (in each gram):

Benzocaine 200mg

Purpose:

Oral Anesthetic

Use:

For oral mucosal use. Use only as directed by dentist. For the temporary relief of pain due to minor dental procedures.

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 occurs, flush with water.
  • Stop use and consult a healthcare 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 swallowed, get medical help or contact a Poison Control Center immediately.
  • If pregnant or breast feeding, ask a health professional before use. 

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions:

Apply only amount needed to the oral mucosa to prevent or relieve pain.

Other Information:

Store at 59°-86°F (15°-30°C). Protect from freezing.

Inactive Ingredients:

Flavoring, PEG 3350, PEG 400, sodium saccharin. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive.

PRIMO TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69509-007
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 
POLYETHYLENE GLYCOL 400 
SACCHARIN SODIUM 
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69509-007-3030 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/01/2014
Labeler - Tri State Dental (176048478)

 
Tri State Dental

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Medically reviewed on Feb 19, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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