Topicale Xtra Gel - Jammin' Strawberry
- Manufacturer
- Medical Products Laboratories,Inc.
- Effective date
- 2024-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:37
Label at a glance#
ProductTopicale Xtra
Active ingredientBENZOCAINE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%
OTC - PURPOSE SECTION
Oral Anesthetic
INDICATIONS & USAGE SECTION
For the temporary relief of minor pain irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedure, minor irritation 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 light headedness, fatigue or lack of energy.
Contraindications:
Do not use in large quantities or over large areas of body
Do not use for Teething
Do not use in children under 2 years of age
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.
Do not use more than directed.
OTC - ASK DOCTOR SECTION
Stop use and ask a doctor
1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting
2. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
DOSAGE & ADMINISTRATION SECTION
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 # 40, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium
INFORMATION FOR OWNERS/CAREGIVERS SECTION
Peel for Drug Facts
NDC 10733-176-01
Premier
Topicale Xtra
Topical Anesthetic Gel
Benzocaine, 20 %
REF 9007154 Jammin' Strawberry 28.35g (1 o.z.)
For Topical Use only - Not for Injection
Contains: 20 % Benzocaine in a specially designed glycol base
Made in U.S.A.
premierdentalco.com
Manufactured for: Premier® Dental Products Company,
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A.
Mfg: Medical Products Laboratories, Inc.
9990 Global Road Philadelphia, PA 19115 U.S.A.
1120049 MPL Rev5 . 2000267(00)
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 premierdentalco.com.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 238910 | benzocaine 20 % Oral Gel | PSN | 4 |
| 864735 | Topicale Xtra 20 % Oral Gel | PSN | 4 |
| 864735 | benzocaine 0.2 MG/MG Oral Gel [Topicale] | SBD | 4 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 4 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 4 |
| 864735 | Topicale 0.2 MG/MG Oral Gel | SY | 4 |
| 864735 | Topicale 20 % Oral Gel | SY | 4 |
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 |
|---|---|---|---|---|---|---|
| 10733-176-01 | Topicale Xtra | 28.35 g in 1 BOTTLE, PLASTIC | GEL | 28.35 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Topicale Xtra
- Benzocaine
- WATER
- SACCHARIN SODIUM
- BENZALKONIUM CHLORIDE
- CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)
- POLYETHYLENE GLYCOL 400
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10733-176 | 10733-176-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) | K6MOM3T5YL | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
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 Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | e3da0e63-a891-72bd-e053-2a95a90a58bc | 2024-12-11 | Warnings | 10733-176-01 10733-176 10733017601 28dd1dbf-cda2-de75-e063-6294a90a48f6 e3da0e63-a891-72bd-e053-2a95a90a58bc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.