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NDC 00135-0603-01 Sensodyne Pronamel 50; 1.15 mg/g; mg/g Details

Sensodyne Pronamel 50; 1.15 mg/g; mg/g

Sensodyne Pronamel is a ORAL 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	00135-0603
Product ID	0135-0603_52cc971b-ced0-403f-bac5-95a4961ca02d
Associated GPIs	97503000004400
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 Pronamel
Proprietary Name Suffix	Strong and Bright Enamel Extra Fresh
Non-Proprietary Name	potassium nitrate and sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	ORAL
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 00135-0603-01 (00135060301)

Pricing Information	N/A
NDC Package Code	0135-0603-01
Billing NDC	00135060301
Package	1 TUBE in 1 CARTON (0135-0603-01) / 85 g in 1 TUBE
Marketing Start Date	2016-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL be1ae382-0e01-4db8-90d7-fdadec2ff861 Details

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% 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 25°C (77°F)

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0602-01

SENSODYNE

PRONAMEL

STRONG & Bright

ENAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

STRONG ENAMEL

WHITER TEETH*

MINT

No. 1 DENTIST RECOMMENDED BRAND

FOR STRENGTHENING AND PROTECTING ENAMEL

*vs. ProNamel Daily Protection

NET WT 3.0 OZ (85 g)

Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

Sensodyne ProNamel STRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

*vs. ProNamel Daily Protection

With twice daily brushing, the dual action formulation:

•: Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
•: Polishes away stains for WHITER BRIGHTER TEETH.

FRESHENS breath and fights CAVITIES

GSK Consumer Healthcare

Warren, NJ 07059

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

ALWAYS FOLLOW THE LABEL

105491XC

Principal Display Panel

NDC 0135-0603-01

SENSODYNE

PRONAMEL

STRONG & Bright

ENAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

STRONG ENAMEL

WHITER TEETH*

EXTRA FRESH

No. 1 DENTIST RECOMMENDED BRAND

FOR STRENGTHENING AND PROTECTING ENAMEL

*vs. ProNamel Daily Protection

NET WT 3.0 OZ (85 g)

Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

Sensodyne ProNamelSTRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

*vs. ProNamel Daily Protection

With twice daily brushing, the dual action formulation:

•: Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
•: Polishes away stains for WHITER BRIGHTER TEETH.

FRESHENS breath and fights CAVITIES

GSK Consumer Healthcare

Warren, NJ 07059

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

ALWAYS FOLLOW THE LABEL

105488XC

INGREDIENTS AND APPEARANCE

SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL MINT

potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0602
Route of Administration	ORAL

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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0602-01	1 in 1 CARTON	12/19/2016
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0135-0602-02	1 in 1 CARTON	12/19/2016
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	12/19/2016

SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL EXTRA FRESH

potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0603
Route of Administration	ORAL

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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0603-01	1 in 1 CARTON	12/19/2016
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	12/19/2016

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

Revised: 12/2020

Document Id: 52cc971b-ced0-403f-bac5-95a4961ca02d

Set id: be1ae382-0e01-4db8-90d7-fdadec2ff861

Version: 3

Effective Time: 20201214

Search by Drug Name or NDC

NDC 00135-0603-01 Sensodyne Pronamel 50; 1.15 mg/g; mg/g Details

Sensodyne Pronamel 50; 1.15 mg/g; mg/g

Product Information

Package

Package Images

NDC 00135-0603-01 (00135060301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL be1ae382-0e01-4db8-90d7-fdadec2ff861 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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