Active ingredient
Benzocaine 10%
Family wellness oral pain relief gel
- Manufacturer
- Velocity Pharma LLC
- Effective date
- 2020-07-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:19:58
Label at a glance#
ProductFamily wellness Regular
Active ingredientBENZOCAINE
Label structure11 sections
Label contents#
Full prescribing information#
Purpose
Oral pain reliever
Use
- for the temporary relief of pain due to toothaches
Warnings
Methemoglobinemla: see package warning.
OTC - DO NOT USE SECTION
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
- For teething
- in children under 2 year of age.
OTC - ASK DOCTOR SECTION
Stop use and ask a physician if
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN:
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away
DOSAGE & ADMINISTRATION SECTION
Directions - cut open tip of tube on score mark
- Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
- Children between 2 and 12 years of age - Should be supervised in the use of this product
- Children under 2 years of age - Ask a physicaian or healthcare provider
Other information
- do not use if tape seal on the flaps of outer packaging are damaged or miissing
- Retain outer packaging for full product uses,directions and warnings.
Inactive ingredients
ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76168-607-33 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-dc9c-a426-e053-dadaa90af4c2 | Family wellness oral pain relief gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76168-607-33 | Family wellnessRegular | 1 in 1 PACKAGE | GEL | 1 | 1 | |
| 76168-607-33 | Family wellnessRegular | 9 g in 1 TUBE | GEL | 9 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Family wellness Regular
- Benzocaine 10%
- AMMONIUM GLYCYRRHIZATE
- POLYETHYLENE GLYCOL 1000
- SACCHARIN SODIUM
- SORBIC ACID
- BENZOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76168-607 | 76168-607-33 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| a97a043f-6e8e-666a-e053-2995a90a3d89 | a97a6682-49ec-477c-e053-2a95a90a0bec | 2020-07-02 | Warnings | a97a043f-6e8e-666a-e053-2995a90a3d89 a97a6682-49ec-477c-e053-2a95a90a0bec |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.