Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.5 mg)

Inactive Ingredients

Water Sorbitol Hydrated Silica Glycerin Polyethylene Glycol 400 Cocamidopropyl Betaine Xanthan Gum Saccharin Sodium Sucralose Titanium Dioxide Sodium Hydroxide D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

Color: white Color: green

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-07-15

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride (0.15% w/v fluoride ion)

Use

aids in the prevention of dental cavities

Directions

Adults and children over 12 years

•
apply toothpaste onto a soft bristle toothbrush
•
brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.

Active Ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

Other Information

store below 25°C (77F°)

Questions Or Comments?

call toll-free 1-800-922-5856 weekdays

Principal Display Panel

NDC 0135-0557-01

biotene ^®

FLUORIDE TOOTHPASTE

GENTLE FORMULA

SPECIALLY FORMULATED TO NOT IRRITATE

FRESH MINT ORIGINAL

NET WT 4.3 OZ (121.9g)

FROM THE MAKERS OF BIOTENE

#1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS

HELPS MAINTAIN ORAL ENVIRONMENT

•
HELPS FRESHEN BAD BREATH
•
SLS FREE
•
BALANCED PH
•
GENTLE FORMULA
•
ESSENTIAL FLUORIDE TOOTH PROTECTION

Also look for other biotene^® products including biotene^® Oral Rinses, biotene^® oralbalance Gel, and biotene^® Mouth Spray.

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies.

www.biotene.com

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

102875XC

Inactive Ingredients (gentle Mint)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, D&C Yellow #10, FD&C Blue #1

Inactive Ingredients (fresh Mint Original)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide

Keep Out of Reach of Children 12 Years of Age and Under. (pbf)

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional. Do not use if you are allergic to any of the ingredients.

Keep Out of Reach of Children 12 Years of Age and Under (fresh Mint and Gentle Mint)

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients.

Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Directions

Adults and children over 12 years

•
apply toothpaste onto a soft bristle toothbrush
•
brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.

Active Ingredient (Active ingredient)

Sodium Fluoride (0.15% w/v fluoride ion)

Other Information (Other information)

store below 25°C (77F°)

Questions Or Comments? (Questions or comments?)

call toll-free 1-800-922-5856 weekdays

Principal Display Panel

NDC 0135-0557-01

biotene ^®

FLUORIDE TOOTHPASTE

GENTLE FORMULA

SPECIALLY FORMULATED TO NOT IRRITATE

FRESH MINT ORIGINAL

NET WT 4.3 OZ (121.9g)

FROM THE MAKERS OF BIOTENE

#1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS

HELPS MAINTAIN ORAL ENVIRONMENT

•
HELPS FRESHEN BAD BREATH
•
SLS FREE
•
BALANCED PH
•
GENTLE FORMULA
•
ESSENTIAL FLUORIDE TOOTH PROTECTION

Also look for other biotene^® products including biotene^® Oral Rinses, biotene^® oralbalance Gel, and biotene^® Mouth Spray.

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies.

www.biotene.com

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

102875XC

Inactive Ingredients (gentle Mint) (Inactive ingredients (Gentle Mint))

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, D&C Yellow #10, FD&C Blue #1

Inactive Ingredients (fresh Mint Original) (Inactive ingredients (Fresh Mint Original))

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide

Keep Out of Reach of Children 12 Years of Age and Under. (pbf) (Keep out of reach of children 12 years of age and under. (PBF))

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional. Do not use if you are allergic to any of the ingredients.

Keep Out of Reach of Children 12 Years of Age and Under (fresh Mint and Gentle Mint) (Keep out of reach of children 12 years of age and under (Fresh Mint and Gentle Mint))

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients.

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity", "Directions": "Adults and children over 12 years • apply toothpaste onto a soft bristle toothbrush • brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.", "Active ingredient": "Sodium Fluoride (0.15% w/v fluoride ion)", "Other information": "store below 25°C (77F°)", "Questions or comments?": "call toll-free 1-800-922-5856 weekdays", "Principal Display Panel": "NDC 0135-0557-01 biotene ® FLUORIDE TOOTHPASTE GENTLE FORMULA SPECIALLY FORMULATED TO NOT IRRITATE FRESH MINT ORIGINAL NET WT 4.3 OZ (121.9g) FROM THE MAKERS OF BIOTENE #1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS HELPS MAINTAIN ORAL ENVIRONMENT • HELPS FRESHEN BAD BREATH • SLS FREE • BALANCED PH • GENTLE FORMULA • ESSENTIAL FLUORIDE TOOTH PROTECTION Also look for other biotene ® products including biotene ® Oral Rinses, biotene ® oralbalance Gel, and biotene ® Mouth Spray. ALWAYS FOLLOW THE LABEL This product contains no Sodium Lauryl Sulfate (SLS) Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies. www.biotene.com Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2014 GSK 102875XC", "Inactive ingredients (Gentle Mint)": "Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, D&C Yellow #10, FD&C Blue #1", "Inactive ingredients (Fresh Mint Original)": "Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide", "Keep out of reach of children 12 years of age and under. (PBF)": "If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional. Do not use if you are allergic to any of the ingredients.", "Keep out of reach of children 12 years of age and under (Fresh Mint and Gentle Mint)": "If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information