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NDC 00135-0450-01 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	00135-0450
Product ID	0135-0450_b6b53ab0-82ee-459a-be1a-14e12c2582f5
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 PRONAMEL
Proprietary Name Suffix	mineral BOOST refreshing peppermint
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 00135-0450-01 (00135045001)

Pricing Information	N/A
NDC Package Code	0135-0450-01
Billing NDC	00135045001
Package	1 TUBE in 1 CARTON (0135-0450-01) / 118 g in 1 TUBE
Marketing Start Date	2021-01-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b6b53ab0-82ee-459a-be1a-14e12c2582f5 Details

Active ingredient

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

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 (77°F)

Inactive ingredients (refreshing peppermint)

water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin

Inactive ingredients (whitening action)

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

Questions or comments?

1-866-844-2797

Additional Information

Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

Minerals keep enamel strong and white. But acidic foods & drinks can dissolve surface minerals. Your saliva naturally replenishes minerals but can’t always keep up, leading to enamel loss.

Pronamel Mineral Boost improves natural mineral absorption for strong white teeth, protected from sensitivity.

ACIDS DISSOLVE SURFACE MINERALS…

…PRONAMEL BOOSTS MINERAL ABSORPTION FROM SALIVA

Replenishes vital minerals in enamel.

Developed to maximize the effect of fluoride to boost the absorption of calcium & phosphate into the enamel surface.

With twice-daily brushing, Pronamel helps to:

•: Protect against effects of dietary acids
•: Prevent enamel loss
•: Relieve sensitive teeth
•: Protect against cavities
•: Clean and freshen your mouth

Recyclable Carton

Save Water

Turn off tap while 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 0135-0450-01

SENSODYNE

PRONAMEL

MINERAL BOOST

new

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Replenishes Vital Minerals

For Stronger, Healthier Enamel

infused with refreshing peppermint

NET WT 4.0 OZ (113g)

gsk

62000000049368

Sensodyne Pronamel Mineral Boost refreshing peppermint 4.0 oz carton

Principal Display Panel

NDC 0135-0480-01

SENSODYNE

PRONAMEL

MINERAL BOOST

new

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Replenishes Vital Minerals

For Stronger, Healthier Enamel

With gentle whitening action

NET WT 4.0 OZ (113g)

gsk

62000000049369

Sensodyne Pronamel Mineral Boost whitening action 4.0 oz carton

INGREDIENTS AND APPEARANCE

SENSODYNE PRONAMEL MINERAL BOOST REFRESHING PEPPERMINT

potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0450
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)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0450-01	1 in 1 CARTON	01/04/2021
1		118 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	01/04/2021

SENSODYNE PRONAMEL MINERAL BOOST WHITENING ACTION

potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0480
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)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0480-01	1 in 1 CARTON	01/04/2021
1		118 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0135-0480-02	1 in 1 CARTON	01/04/2021
2		77 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	01/04/2021

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

Revised: 8/2020

Document Id: b6b53ab0-82ee-459a-be1a-14e12c2582f5

Set id: b6b53ab0-82ee-459a-be1a-14e12c2582f5

Version: 1

Effective Time: 20200825

Search by Drug Name or NDC

NDC 00135-0450-01 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 00135-0450-01 (00135045001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b6b53ab0-82ee-459a-be1a-14e12c2582f5 Details

Active ingredient

Purpose

Uses

Warnings

Stop use and ask a dentist if

Keep out of reach of children.

Directions

Other information

Inactive ingredients (refreshing peppermint)

Inactive ingredients (whitening action)

Questions or comments?

Additional Information

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

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