MedPath

GuruNanda Sensitive

Approved
Approval ID

3ef0d3d4-fd42-0181-e063-6394a90af09c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

GURUNANDA, LLC

DUNS: 079671169

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Potassium Nitrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70708-645
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Potassium Nitrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (24)

SEA SALTInactive
Code: 87GE52P74G
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MENAQUINONE-7Inactive
Code: 8427BML8NY
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF OILInactive
Code: LAV5U5022Y
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
TURMERIC OILInactive
Code: 6KGS8SP16U
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM COCOYL GLUTAMATEInactive
Code: BMT4RCZ3HG
Classification: IACT
.ALPHA.-TOCOPHEROL, D-Inactive
Code: N9PR3490H9
Classification: IACT
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
STEVIA LEAFInactive
Code: 6TC6NN0876
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
POTASSIUM NITRATEActive
Quantity: 50 mg in 1 g
Code: RU45X2JN0Z
Classification: ACTIB
CALCIUM HYDROXYAPATITEInactive
Code: 91D9GV0Z28
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEInactive
Code: FJ1H6M2JG9
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CLOVE OILInactive
Code: 578389D6D0
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
THYME OILInactive
Code: 2UK410MY6B
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

08645

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

Use

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/19/2025

Active ingredient

Potassium nitrate 5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/19/2025

Purpose

Antihypersensitivity

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2025

Warnings

Warnings

When using this product

if pain/sensitivity still persists after 4 weeks of use, stop use and contact your dentist.

Stop use and ask a dentist

if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children.

If more than used for brusing is accidently swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

Directions

Adults and children 12 years of age and older:

  • Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (mroning and evening) or as recommended by a dentist or doctor.
  • Make sure to brush all sensitive areas of the teeth.

Children under 12 years of age:

  • Consult a dentist or doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/19/2025

Other information

Do not use if the foil seal on the tube is broken or missing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2025

Inactive ingredients

Water, Glycerin, Hydrated Silica, Xylitol, Sorbitol, Calcium Hydroxyapatite, Cocamidopropyl Betaine, Sodium Cocoyl Glutamate, Xanthan Gum, Stevia Leaf Extract, Natural Flavor, D-Alpha Tocopherol, Sodium Bicarbonate, Menthol, Wintergreen Oil, Arginine, Celtic Sea Salt, White Turmeric Oil, Eucalyptus Oil, Clove Oil, Peppermint Oil, White Thyme Oil, Menaquinone-7 (Vitamin K2), Caprylic/Capric/Lauric Triglyceride

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GuruNanda Sensitive - FDA Drug Approval Details