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NDC 00135-5026-03 Sensodyne 50; 1.15 mg/g; mg/g Details

Sensodyne 50; 1.15 mg/g; mg/g

Sensodyne is a DENTAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is POTASSIUM NITRATE; SODIUM FLUORIDE.

Product Information

NDC	00135-5026
Product ID	0135-5026_d02580a5-d7e1-47a5-8fca-78ed88df2bc5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sensodyne
Proprietary Name Suffix	Nourish Gently Soothing
Non-Proprietary Name	potassium nitrate and sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	DENTAL
Active Ingredient Strength	50; 1.15
Active Ingredient Units	mg/g; mg/g
Substance Name	POTASSIUM NITRATE; SODIUM FLUORIDE
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00135-5026-03 (00135502603)

Pricing Information	N/A
NDC Package Code	0135-5026-03
Billing NDC	00135502603
Package	23 g in 1 TUBE (0135-5026-03)
Marketing Start Date	2023-01-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5403ab67-532c-4bdf-9b06-07b1866f37f1 Details

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

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: Consult a dentist or doctor.

Other information

•: do not store above 25°C (77°F)

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, flavor (contains aloe barbadensis extract and cocos nucifera (coconut) oil), sodium lauryl sulfate, xanthan gum, cocamidopropyl betaine, sodium saccharin, titanium dioxide

Questions or comments?

1-866-844-2797

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE nourish

WITH BIO-ACTIVE MINERALS

Brush twice daily for a healthier smile:

•: Strengthens & nourishes teeth
•: Helps prevent cavities
•: Protects from sensitivity*
•: Freshens breath

The Sensodyne Nourish range with bio-active minerals, strengthens and nourishes teeth while also protecting from sensitivity*. Our toothpaste is designed to provide the everyday nourishment your teeth to help protect the health of your mouth.

Gently Soothing: With trusted sensitivity protection*, our formulation, blended with aloe vera extract and natural mint, is designed for a clean sensation.

*with twice daily brush

Help us support the planet by recycling our packaging and being responsible with water usage.

CARTON

RECYCLE

TUBE

RECYCLE

LOT

See end of carton

Save Water

Turn off tap whilst brushing

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Principal Display Panel

NDC 0135-5026-01

NEW

SENSODYNE

nourish

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NOURISH & STRENGTHEN TEETH FOR A HEALTHY MOUTH

gently soothing

aloe vera & natural mint

WITH BIO-ACTIVE MINERALS

NET WT 4.0 OZ (113 g)

62000000064835 Front Carton

Sensodyne Nourish Gently Soothing 4.0oz (113g) carton

INGREDIENTS AND APPEARANCE

SENSODYNE NOURISH GENTLY SOOTHING

potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-5026
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	1.15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT OIL (UNII: Q9L0O73W7L)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-5026-01	1 in 1 CARTON	01/03/2022
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0135-5026-02	1 in 1 CARTON	03/25/2022
2		23 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:0135-5026-03	23 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/03/2022

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 9/2022

Document Id: d02580a5-d7e1-47a5-8fca-78ed88df2bc5

Set id: 5403ab67-532c-4bdf-9b06-07b1866f37f1

Version: 2

Effective Time: 20220906