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
Benzocaine Gel
FDA Label NDC 66467-4002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Darby Dental Supply, Llc for the product Benzocaine (NDC 66467-4002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients (in each gram), purpose, use, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
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)
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)
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)
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)
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
Principal Display Panel (30 g Jar Label)
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