SensiCaine Topical Anesthetic Gel Raspberry Flavor
- Manufacturer
- Safco Dental Supply Co.
- Effective date
- 2017-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:53:30
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
INGREDIENTS
Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40, FD&C Blue #1 and D&C Red #28.
USUAL DOSAGE
For oral mucosal use only as directed by a dentist.
WARNING
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.
HOW SUPPLIED SECTION
STORAGE AND HANDLING SECTION
Store at controlled room temperature 59-86°F (15-30°C).
INDICATIONS & USAGE SECTION
CAUTION
Federal law prohibits dispensing without a prescription.
SPL UNCLASSIFIED SECTION
Distributed by:
Safco Dental Supply Co.
Buffalo Grove, IL 60089
800-621-2178
www.safcodental.com
PRINCIPAL DISPLAY PANEL - Jar Label
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67239-0208-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1732-f424-e053-dadaa90a57ce | SensiCaine Topical Anesthetic Gel Raspberry Flavor |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67239-0208-1 | Topical Anesthetic Raspberry | 34 g in 1 JAR | GEL | 34 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67239-0208 | TOPICAL ANESTHETIC RASPBERRY (BENZOCAINE) GEL [SAFCO DENTAL SUPPLY CO.] | 2 | Legacy NDC, 1 package rows | 20171217_d20d9113-73d6-47aa-af04-abcb3b4f97e5.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| Benzocaine | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Polyethylene Glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | 1 | |
| Polyethylene Glycol 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| Saccharin Sodium Dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Topical Anesthetic Raspberry
- Benzocaine
- Polyethylene Glycol 400
- Saccharin Sodium
- Polyethylene Glycol 3350
- Water
- FD&C RED NO. 40
- FD&C BLUE NO. 1
- D&C RED NO. 28
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67239-0208 | 67239-0208-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| Polyethylene Glycol 400 | B697894SGQ | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Polyethylene Glycol 3350 | G2M7P15E5P | IACT |
| Water | 059QF0KO0R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRAVENOUS | 0.5 ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | CAPSULE / ORAL | 576 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAMUSCULAR | 406 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SWAB / TOPICAL | 5250 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, CHEWABLE / ORAL | 15 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION, SUSPENSION / SOFT TISSUE | 87 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LOTION / TOPICAL | 5 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAMUSCULAR | 20.3 %w/v | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, EXTENDED RELEASE / ORAL | 61 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAVENOUS | 24186 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | TABLET / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 2 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, FILM COATED / ORAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAVENOUS | 28216 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUSPENSION / ORAL | 900 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SPRAY, METERED / NASAL | 320 mg | ||
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | SUPPOSITORY / RECTAL | 5704 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | AEROSOL, POWDER / TOPICAL | NA | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SYRUP / ORAL | 740 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2daf68dc-8cb7-4295-ac6d-b1b8dfc664eb | d20d9113-73d6-47aa-af04-abcb3b4f97e5 | 2017-12-17 | Warnings | 2daf68dc-8cb7-4295-ac6d-b1b8dfc664eb d20d9113-73d6-47aa-af04-abcb3b4f97e5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
