NATEAN CLEAN PLUS SENSITIVITY RELIEF- potassium nitrate, sodium fluoride paste

NATEAN by

Drug Labeling and Warnings

NATEAN by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Potassium nitrate 5%

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

Purposes

Antihypersensitivity

Anticavity

Uses

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

Warnings

When using this product,if irritation occurs discontinue use.

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.
• 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.

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 (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

• do not store above 25°C (77F°)

Inactive ingredients

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?

1-800-733-5879

Additional Information

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

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

INGREDIENTS AND APPEARANCE

NATEAN   CLEAN PLUS SENSITIVITY RELIEF
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-1250
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
XANTHAN GUM (UNII: TTV12P4NEE)
REBAUDIOSIDE A (UNII: B3FUD0528F)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT (Soothing Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-1250-01	1 in 1 CARTON	01/03/2022
1		133 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/03/2022

Labeler - Haleon US Holdings LLC (079944263)