Indications and uses
temporarily relieves pain associated with the following mouth and gum irritations: toothache canker sores minor dental procedures dentures sore gums braces
Benzocaine 20% pain relieving gel
- Manufacturer
- FAMILY DOLLAR SERVICES INC
- Effective date
- 2025-10-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:38:15
Label at a glance#
ProductFamily Wellness Oral Pain Relief
Active ingredientBENZOCAINE
Label structure8 sections
Dosage and administration
adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age adult supervision should be given in the use of this product children under 2 years of age do not use For denture irritation: apply thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well...
Label contents#
Full prescribing information#
Active ingredients
Benzocaine 20%
Purpose
Oral pain reliever
Uses
temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- canker sores
- minor dental procedures
- dentures
- sore gums
- braces
Warnings
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, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Allergy alert:Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Do not use:
- for teething
- in children under 2 years of age
When using this product:
- avoid contact with the eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless directed by a doctor/dentist
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness lasts or worsens
- swelling, rash, or fever develops
Keep out of reach of children
Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
| adults and children 2 years of age and over | apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist |
| children under 12 years of age | adult supervision should be given in the use of this product |
| children under 2 years of age | do not use |
- For denture irritation:
- apply thin layer to the affected area
- do not reinsert dental work until irritation/pain is relieved
- rinse mouth well before reinserting
Other information
- store at 20-25°C (68-77°F)
- do not refrigerate
Inactive ingredients
benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene 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 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-108-14 | Family WellnessOral Pain Relief | 1 in 1 CARTON | GEL | 1 | 3 | |
| 55319-108-14 | Family WellnessOral Pain Relief | 14 g in 1 TUBE | GEL | 14 | 3 |
Products#
Every source-derived product name is available through these pages.
- Family Wellness Oral Pain Relief
- Benzocaine 20%
- BENZOCAINE
- GLYCERIN
- POLYSORBATE 80
- PROPYLENE GLYCOL
- SACCHARIN SODIUM
- D&C RED NO. 33
- FD&C YELLOW NO. 6
- BENZYL ALCOHOL
- FD&C BLUE NO. 1
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SORBIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-108 | 55319-108-14 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| SORBIC ACID | X045WJ989B | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-01-09 | full-release | 2026-06-01 00:51:44 |
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 |
|---|---|---|---|---|---|---|
| Family Wellness Oral Pain Relief | BENZOCAINE 20% | FAMILY DOLLAR SERVICES INC | 105d87d6-9147-43d4-e063-6394a90a57ee | 2025-10-08 | Warnings | 55319-108-14 55319-108 55319010814 40ab3bb4-cbc0-b9e1-e063-6294a90a5a0f 105d87d6-9147-43d4-e063-6394a90a57ee |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.