Borax

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:48

Label at a glance#

ProductBorax
Active ingredientSODIUM BORATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingedient** (in each pellet)

Borax 6C HPUS (0.44 mg)

The letters "HPUS" indicate that the component in this product is offically monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Relieves minor canker sore pain or mouth irritations

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves symptoms of canker sores or minor mouth and gum irritations such as:

  • pain
  • soreness
  • discomfort

Tube- Canker Sores*

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 3 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops.

Tube- Stop use and ask a doctor if symptoms persist for more than 3 days or worsen

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

SPL UNCLASSIFIED SECTION

  • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
  • contains 0.25 g of sugar per dose

Canker Sore Relief*

Pain Soreness Discomfort*

3 TUBES

APPROX. 80 PELLETS EACH

TOTAL 240 PELLETS

16 DOSES PER TUBE

Relieves Minor Sores & Irritation from Dentures or Braces*

Turn tube upside down Twist until 5 pellets are dispensed Remove cap and pour pellets under the tongue

Tube-

Do not use if pellet dispenser seal is broken.
Contains approx. 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabellabellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-0889-41Borax6 [hp_C] in 1 TUBEPELLET63
0220-0889-43Borax3 in 1 BOXPELLET33
0220-0889-43Borax6 [hp_C] in 1 TUBEPELLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-0889BORAX (SODIUM BORATE ) PELLET [BOIRON]3Current NDC, Legacy NDC, 3 package rows20230124_8488980e-7b83-4b48-e053-2a91aa0aa202.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-08890220-0889-41, 0220-0889-43

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BoraxSODIUM BORATEBoiron8488980e-7b83-4b48-e053-2a91aa0aa2022023-01-23Exact identifier
ndc (package): 0220-0889-41
ndc (package): 0220-0889-43
ndc (product): 0220-0889
ndc11 (package): 00220088941
ndc11 (package): 00220088943
spl id: f2f61f63-eea2-dc1f-e053-2995a90a5d7e
spl set id: 8488980e-7b83-4b48-e053-2a91aa0aa202

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.