Label: BORAX- sodium borate pellet
- NDC Code(s): 0220-0889-41, 0220-0889-43
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 23, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BORAX
sodium borate pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-0889 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 6 [hp_C] in 6 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color white Score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-0889-41 6 [hp_C] in 1 TUBE; Type 0: Not a Combination Product 03/03/1983 2 NDC:0220-0889-43 3 in 1 BOX 05/12/2022 2 6 [hp_C] in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/03/1983 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-0889)