Topicale Gel Pump
- Manufacturer
- Medical Products Laboratories, Inc.
- Effective date
- 2024-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:28
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Benzocaine 18%
OTC - PURPOSE SECTION
Oral Anesthetic
INDICATIONS & USAGE SECTION
For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances
WARNINGS SECTION
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops pale, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy.
- Do not use for Teething
- Do not use in children under 2 years of age
- Do not use in large quantities or over large areas of body
Allergy Alert:
Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics
When using this product
- Avoid contact with eyes
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of accidental overdose, get medical help or contact a Poison Control Centre immediately
OTC - ASK DOCTOR SECTION
Stop use and ask a doctor
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting
If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
DOSAGE & ADMINISTRATION SECTION
- Do not use more than directed.
Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor.
Children 2-12 years of age - Should be supervised in the use of the product
Children under 2 years of age - Do not use
OTHER SAFETY INFORMATION
- Do not use if imprinted seal under cap is broken or missing
- Store at 68º to 77º F (20º - 25º C)
INACTIVE INGREDIENT SECTION
Benzalkonium Chloride (as a preservative), Carbomers, D&C Red Dye # 33 (Cherry & Raspberry), FD&C Red Dye # 40 (Strawberry), Flavorings, Polyethylene glycol, Purified Water, Saccharin sodium.
INFORMATION FOR OWNERS/CAREGIVERS SECTION
Premier
Topicale
Topical Anestheic Gel
REF
9007141 Cherry
9007142 Raspberry
9007143 Strawberry
9007144 Pina Colada
9007140 Assorted
Made in U.S.A.
Contents: Three 43g Pumps
0518001 Rev4 MPL 317935
Retain drug facts for future reference.
Manufactured for: Premier® Dental Products Company,
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A.
Manufacturer: Medical Products Laboratories, Inc.
9990 Global Road Philadelphia, PA 19115 U.S.A.
Questions or Comments?
888.670.6100 or 610.239.6000
M-Th: 7:30a.m. - 5:30p.m., F: 7:30a.m. - 4:00p.m. EST
To obtain an SDS, contact Customer Service Department or visit
www.premusa.com.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1042838 | benzocaine 18 % Oral Gel | PSN | 3 |
| 1049213 | Topicale 18 % Oral Gel | PSN | 3 |
| 1049213 | benzocaine 0.18 MG/MG Oral Gel [Topicale] | SBD | 3 |
| 1042838 | benzocaine 0.18 MG/MG Oral Gel | SCD | 3 |
| 1042838 | benzocaine 18 % Oral Gel | SY | 3 |
| 1049213 | Topicale 0.18 MG/MG Oral Gel | SY | 3 |
| 1049213 | Topicale 18 % Oral Gel | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10733-167-43 | Topicale | 43 g in 1 BOTTLE, PUMP | GEL | 43 | 3 | |
| 10733-169-43 | Topicale | 43 g in 1 BOTTLE, PUMP | GEL | 43 | 3 | |
| 10733-170-43 | Topicale | 43 g in 1 BOTTLE, PUMP | GEL | 43 | 3 | |
| 10733-171-43 | Topicale | 43 g in 1 BOTTLE, PUMP | GEL | 43 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10733-167 | TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.] | 3 | Current NDC, 1 package rows | 20241213_8281700c-10f9-841c-e053-2991aa0a918f.zip |
| 10733-169 | TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.] | 3 | Current NDC, 1 package rows | 20241213_8281700c-10f9-841c-e053-2991aa0a918f.zip |
| 10733-170 | TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.] | 3 | Current NDC, 1 package rows | 20241213_8281700c-10f9-841c-e053-2991aa0a918f.zip |
| 10733-171 | TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.] | 3 | Current NDC, 1 package rows | 20241213_8281700c-10f9-841c-e053-2991aa0a918f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10733-167-43 | GM - Gram | 10733-167 | 7a8f812c-78dd-4d13-992d-402c63fed35e | 1 | 2022-06-06 |
| 10733-170-43 | GM - Gram | 10733-170 | e1eca815-c57c-4cd8-b68b-7720c5f4c90c | 1 | 2022-06-06 |
| 10733-169-43 | GM - Gram | 10733-169 | 9c8a0938-9779-4e2d-83d8-a058770fae8f | 1 | 2022-06-06 |
| 10733-171-43 | GM - Gram | 10733-171 | 1c36ad69-dffd-43be-a052-acc324fd4e98 | 1 | 2022-06-06 |
Products#
Every source-derived product name is available through these pages.
- Topicale
- Benzocaine
- CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)
- BENZALKONIUM CHLORIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SACCHARIN SODIUM
- SACCHARIN
- D&C RED NO. 33
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10733-167 | 10733-167-43 |
| 10733-170 | 10733-170-43 |
| 10733-169 | 10733-169-43 |
| 10733-171 | 10733-171-43 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8281700c-10f9-841c-e053-2991aa0a918f | 2024-12-11 | Warnings | 10733-169-43 10733-170-43 10733-171-43 10733-167-43 10733-171 10733-170 10733-167 10733-169 10733017043 10733016743 10733016943 10733017143 28dd17ff-9097-d336-e063-6394a90a00fd 8281700c-10f9-841c-e053-2991aa0a918f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.




