Dosage and administration
Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours. Children under 6 months of age: Consult a dentiest or doctor.
Benzoin Tincture
- Manufacturer
- Humco Holding Group, Inc.
- Effective date
- 2020-06-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:18:22
Label at a glance#
ProductBenzoin Tincture
Active ingredientBENZOIN RESIN
Label structure12 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient
Benzoin
Purpose
Protectant
Use
Forms a coating over wound for protecting recurring canker sores
Warnings
For external 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 for 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 reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours.
Children under 6 months of age: Consult a dentiest or doctor.
Other information
Flammable: Keep away from spark, heat or flame.
Inactive Ingredients
Alcohol 77%, Aloe, Storax, Tolu Balsam
SM
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0395-9107-92 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b0b1-d8a0-e053-dadaa90a6e4e | Private Label Benzoin Tincture |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0395-9107-92 | Benzoin Tincture | 59 mL in 1 BOTTLE, PLASTIC | LIQUID | 59 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|
| 0395-9107 | 0395-9107-92 |
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#
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 |
|---|---|---|---|---|---|---|
| a878b139-8995-e154-e053-2995a90a621e | 60517f09-674c-ea0c-e053-2991aa0a9b92 | 2020-06-19 | Warnings | a878b139-8995-e154-e053-2995a90a621e 60517f09-674c-ea0c-e053-2991aa0a9b92 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.