FDA.reportPublic FDA data

NATEAN

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:04

Label at a glance#

ProductNATEAN Clean plus Sensitivity Relief
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections

Indications and uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.

Dosage and administration

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 (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult...

Storage and handling

do not store above 25°C (77F°)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

Uses

INDICATIONS & USAGE SECTION

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

When using this product,if irritation occurs discontinue use.

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • Children under 12 years of age:Consult a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

  • do not store above 25°C (77F°)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, glycerin, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, xanthan gum, rebaudioside A, cocos nucifera (coconut) oil, aloe barbadensis leaf extract, maltodextrin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-733-5879

Additional Information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

Natean was created by a small passionate team of scientists and herbalists on a mission to give you the best of what nature and science can offer, while minimizing our impact to the planet. Our toothpastes expertly balance powerful, scientifically studied ingredients with botanicals for a clean you can feel, and a clean you can feel good about.

NATEAN-INSPIRED BY NATURE AND DESIGNED TO BE CLEAN

RELIEVES SENSITIVE TEETH AND LEAVES YOUR MOUTH FEELING CLEAN AND FRESH

  • Infused with natural orange blossom and mint flavor, and extracts from aloe vera and coconut
  • Contains fluoride to fight cavities
  • Helps control tartar build-up with twice daily brushing

*No animal origin materials used in the processing of these products. Contains no animal ingredients or derivatives.

†Recycling facilities for this product may not exist in your area

BPA-FREE TUBE

Tube contains post consumer recycled plastic

Recycleable carton, tube & cap

Distributed by: Alacer Corp.Carlisle, PA 17013

© 2021 Alacer Corp.

www.nateantoothpaste.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-1250-01

Natean

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NATURAL FLAVORS AND SWEETENERS

NON-GMO / GLUTEN-FREE

NO ARTIFICIAL PRESERVATIVES,

COLORS, DYES

NO SLS/TRICLOSAN

VEGAN-FRIENDLY*

INFUSED WITH

BOTANICALS

CLEAN + SENSITIVITY RELIEF

SOOTHING MINT

NET WT 4.7 OZ (133g)

1001587 Front Carton

Natean Clean+Sensitivity Relief 4.7 OZ
Natean Clean+Sensitivity Relief 4.7 OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN2
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD2
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY2
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-1250-01NATEANClean plus Sensitivity Relief133 g in 1 TUBEPASTE1332
0135-1250-01NATEANClean plus Sensitivity Relief1 in 1 CARTONPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-1250NATEAN CLEAN PLUS SENSITIVITY RELIEF (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC, 2 package rows20240321_cea6f992-8a44-4eb8-baea-97b7b181b227.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-12500135-1250-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
XANTHAN GUMTTV12P4NEEIACT
REBAUDIOSIDE AB3FUD0528FIACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
NATEAN Clean plus Sensitivity ReliefPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcea6f992-8a44-4eb8-baea-97b7b181b2272024-03-19WarningsExact identifier
ndc (package): 0135-1250-01
ndc (product): 0135-1250
ndc11 (package): 00135125001
spl id: 14084468-126f-1f14-e063-6394a90a9c69
spl set id: cea6f992-8a44-4eb8-baea-97b7b181b227

Reported adverse events (FAERS/openFDA)#

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