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NDC 00135-0581-01 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	00135-0581
Product ID	0135-0581_40e3fe1a-6f43-40ab-a98c-dc43bc266f52
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	True white
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 00135-0581-01 (00135058101)

Pricing Information	N/A
NDC Package Code	0135-0581-01
Billing NDC	00135058101
Package	1 TUBE in 1 CARTON (0135-0581-01) / 85 g in 1 TUBE
Marketing Start Date	2015-12-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 671f8f45-389c-4375-be43-f5500ee21a0e Details

Active ingredients

Potassium nitrate 5%**

Sodium fluoride 0.25% (0.16% w/v fluoride ion)

Purpose

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: Consult a dentist or doctor.

Other information

•: store below 30°C (86°F)

Inactive ingredients

sorbitol, water, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0581-01

SENSODYNE®

TRUE

white®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

Sensitivity Relief*

Stain Prevention • Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

FOR SENSITIVE TEETH

NET WT 3.0 OZ (85 g)

Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne® True White® has the lowest abrasion formulation ever in a Sensodyne® toothpaste.

With twice daily brushing it:

•: is proven to relieve sensitivity pain
•: helps to gently whiten your teeth
•: leaves a protective shield to help prevent new stains forming
•: freshens breath, fights cavities and helps keep gums healthy

*with twice daily brushing

**maximum FDA sensitivity active ingredient

GSK Consumer Healthcare

Warren, NJ 07059

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

ALWAYS FOLLOW THE LABEL

105639XA

Principal Display Panel

NDC 0135-0579-01

SENSODYNE®

TRUE

white®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

EXTRA FRESH

Sensitivity Relief*

Stain Prevention • Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

FOR SENSITIVE TEETH

NET WT 3.0 OZ (85 g)

Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne® True White® has the lowest abrasion formulation ever in a Sensodyne® toothpaste.

With twice daily brushing it:

•: is proven to relieve sensitivity pain
•: helps to gently whiten your teeth
•: leaves a protective shield to help prevent new stains forming
•: freshens breath, fights cavities and helps keep gums healthy

*with twice daily brushing

**maximum FDA sensitivity active ingredient

GSK Consumer Healthcare

Warren, NJ 07059

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

ALWAYS FOLLOW THE LABEL

105640XA

INGREDIENTS AND APPEARANCE

SENSODYNE TRUE WHITE

potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0581
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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0581-01	1 in 1 CARTON	12/21/2015
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0135-0581-02	1 in 1 CARTON	12/21/2015
2		23 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	12/21/2015

SENSODYNE TRUE WHITE

potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0579
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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (extra fresh)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0579-01	1 in 1 CARTON	12/21/2015
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	12/21/2015

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

Revised: 12/2020

Document Id: 40e3fe1a-6f43-40ab-a98c-dc43bc266f52

Set id: 671f8f45-389c-4375-be43-f5500ee21a0e

Version: 4

Effective Time: 20201214

Search by Drug Name or NDC

NDC 00135-0581-01 Sensodyne 50; 1.15 mg/g; mg/g Details

Sensodyne 50; 1.15 mg/g; mg/g

Product Information

Package

Package Images

NDC 00135-0581-01 (00135058101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 671f8f45-389c-4375-be43-f5500ee21a0e Details

Active ingredients

Purpose

Uses

Warnings

When using this product,

Stop use and ask a dentist if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

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