FDA Label for Benzocaine Strawberry

View Indications, Usage & Precautions

Benzocaine Strawberry Product Label

The following document was submitted to the FDA by the labeler of this product Darby Dental Supply, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

  • Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • Manufactured by:
    Darby Dental Supply, LLC
    Jericho, NY 11753


Active Ingredients (In Each Gram)



Benzocaine 200 mg


Purpose



Oral Anesthetic


Use



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


Otc - Do Not Use



  • 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.

Otc - When Using



  • When using this product Avoid contact with eyes. If contact occurs, flush with water.

Otc - Stop Use



  • 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.

Otc - Pregnancy Or Breast Feeding



  • If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children



  • 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, water. May contain green #5, red #28, red #40, yellow #5 (tartrazine), as a color additive.


Questions Or Comments?



800-645-2310 or darby.com


Principal Display Panel - 30 G Jar Label - Raspberry



DARBY®
DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel
Topical Anesthetic Gel
Net Contents: 1 oz

DARBY
QUALITY
CERTIFIED

Manufactured by:
Darby Dental Supply, LLC
Jericho, NY 11753

PEEL BACK to review drug facts


Principal Display Panel - 30 G Jar Label - Bubble Gum



DARBY®
DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel
Topical Anesthetic Gel
Net Contents: 1 oz

DARBY
QUALITY
CERTIFIED

Manufactured by:
Darby Dental Supply, LLC
Jericho, NY 11753

PEEL BACK to review drug facts


Principal Display Panel - 30 G Jar Label - Cherry



DARBY®
DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel
Topical Anesthetic Gel
Net Contents: 1 oz

DARBY
QUALITY
CERTIFIED

Manufactured by:
Darby Dental Supply, LLC
Jericho, NY 11753

PEEL BACK to review drug facts


Principal Display Panel - 30 G Jar Label - Mint



DARBY®
DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel
Topical Anesthetic Gel
Net Contents: 1 oz

DARBY
QUALITY
CERTIFIED

Manufactured by:
Darby Dental Supply, LLC
Jericho, NY 11753

PEEL BACK to review drug facts


Principal Display Panel - 30 G Jar Label - Pineapple



DARBY®
DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel
Topical Anesthetic Gel
Net Contents: 1 oz

DARBY
QUALITY
CERTIFIED

Manufactured by:
Darby Dental Supply, LLC
Jericho, NY 11753

PEEL BACK to review drug facts


Principal Display Panel - 30 G Jar Label - Strawberry



DARBY®
DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel
Topical Anesthetic Gel
Net Contents: 1 oz

DARBY
QUALITY
CERTIFIED

Manufactured by:
Darby Dental Supply, LLC
Jericho, NY 11753

PEEL BACK to review drug facts


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