Label: BIOTENE FRESH MINT ORIGINAL- sodium fluoride paste
BIOTENE GENTLE MINT- sodium fluoride paste
- NDC Code(s): 0135-0557-01, 0135-0557-02, 0135-0558-01
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
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.
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.
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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 underask 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.
- Other information
- Inactive ingredients (Fresh Mint Original)
- Inactive ingredients (Gentle Mint)
- Questions or comments?
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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, oralbalanceand 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
-
Principal Display Panel
NDC 0135-0558-01
biotene®
FLUORIDE TOOTHPASTE
GENTLE FORMULA
SPECIALLY FORMULATED TO NOT IRRITATE
GENTLE MINT
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, oralbalanceand graphic elements are trademarks of the GSK group of companies.
Distributed by:
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
©2014 GSK
102874XC
-
INGREDIENTS AND APPEARANCE
BIOTENE FRESH MINT ORIGINAL
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0557 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color white Score Shape Size Flavor MINT (Fresh Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0557-01 1 in 1 CARTON 07/15/2013 1 121.9 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0557-02 1 in 1 CARTON 07/15/2013 2 19.8 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 07/15/2013 BIOTENE GENTLE MINT
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0558 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM HYDROXIDE (UNII: 55X04QC32I) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color green Score Shape Size Flavor MINT (Gentle Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0558-01 1 in 1 CARTON 07/15/2013 1 121.9 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 07/15/2013 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
