Dosage and administration
Adult and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more than every 2 hours. Children under 6 months of age: Consult a dentist or doctor.
Benzoin Tincture
- Manufacturer
- Humco Holding Group, Inc. | Pharma Nobis, LLC
- Effective date
- 2023-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:04:40
Label at a glance#
ProductBenzoin Tincture
Active ingredientBENZOIN RESIN
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient
Benzoin
Purpose
Oral mucosal protectant
Use
Forms a coating over wound for protecting recurring canker sores
Warnings
For externl use only. Do not swallow. Do not exceed recommended dosage.
When using this product
Children under 12 years of age should be supervised in the use of this product.
Do not use more than 7 days unless directed by a dentist or doctor.
Stop use and consult a dentist or doctor if
- sore mouth symptoms do not improve in 7 days.
- irritation, pain or redness persists or worsens.
- swelling, rash or fever develops.
Keep out of the reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immeditely.
Directions
Adult and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more than every 2 hours.
Children under 6 months of age: Consult a dentist or doctor.
Inactive Ingredients
Alcohol 77%, Aloe, Stoax, tolu Balsam.
Questions or Comments?
1-800-662-3435
Principal Display Panel
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0395-0247-92 | Benzoin Tincture | 59 mL in 1 BOTTLE, PLASTIC | LIQUID | 59 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0395-0247-92 | ML - Milliliter | 0395-0247 | cd06e83d-0c16-4f9b-8625-29d3acb4d04e | 1 | 2013-10-17 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOIN RESIN | ACTIVE INGREDIENT | GK21SBA74R | 1 | |
| BENZOIN RESIN | ACTIVE MOIETY | GK21SBA74R | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALOE | INACTIVE INGREDIENT | V5VD430YW9 | 1 | |
| TOLU BALSAM | INACTIVE INGREDIENT | TD2LE91MBE | 1 |
Products#
Every source-derived product name is available through these pages.
- Benzoin Tincture
- Benzoin Resin
- ALCOHOL
- ALOE
- TOLU BALSAM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0395-0247 | 0395-0247-92 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| ALOE | V5VD430YW9 | IACT |
| TOLU BALSAM | TD2LE91MBE | IACT |
| BENZOIN RESIN | GK21SBA74R | ACTIB |
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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 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 |
|---|---|---|---|---|---|---|
| Benzoin Tincture | BENZOIN RESIN | Humco Holding Group, Inc. | b33b5896-673b-498c-8a58-76ece8552f7a | 2023-12-15 | Warnings | 0395-0247-92 0395-0247 00395024792 0c929258-b192-bc2f-e063-6394a90a8e47 b33b5896-673b-498c-8a58-76ece8552f7a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.