Label: PEARL WHITE- potassium nitrate, sodium fluoride paste, dentifrice
- NDC Code(s): 42199-006-05, 42199-006-06
- Packager: Beyond International Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
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DOSAGE & ADMINISTRATION
Directions
Adults and Children 12 years of age and older
- Apply at least a 1-inch strip of toothpaste 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 directed by a dentist or doctor.
- Do not swallow. Spit out after brushing.
Children under 12 years of age: Consult a dentist or doctor.
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
PEARL WHITE
Sensitivity Formula:
- Prevents cavities
- Reduces tartar build-up
- Reduces plaque
- Freshens breath
WITH REGULAR USE:
- Powerful stain remover, Calcium Peroxide, dissolves difficult-to-remove stains deep inside teeth.
- Surface stains are gently polished away.
- Unique formula leaves teeth shiny and sparkling white.
- Soothes the irritated nerves in your teeth.
- Protects against the causes of hypersensitivity.
For a healthy, shiny, white smile: Brush twice a day, floss daily and visit your dentist regularly.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEARL WHITE
potassium nitrate, sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42199-006 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR) GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) SODIUM BENZOATE (UNII: OJ245FE5EU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CALCIUM PEROXIDE (UNII: 7FRO2ENO91) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42199-006-05 1 in 1 CARTON 06/12/2017 11/27/2026 1 120 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:42199-006-06 1 in 1 CARTON 06/12/2017 11/27/2026 2 40 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 06/12/2017 11/27/2026 Labeler - Beyond International Inc. (080721790) Establishment Name Address ID/FEI Business Operations Beyond International Inc 080721790 manufacture(42199-006)
