Label: BRUSH BUDDIES VALUE 2 PACK WHITENING- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 70108-030-01
- Packager: Ashtel Studios, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 25, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions • adults and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow • to minimize swallowing, use a pea-sized amount in children under 6 • Supervise children's brushing until good habits are established • Children under 2 years of age: Consult a dentist or doctor. Do not swallow.
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INACTIVE INGREDIENT
Inactive ingredients calcium carbonate, aqua, sorbitol, precipitated silica, sodium lauryl sulphate, flavor, sodium silicate, tetra sodium pyrophosphate, xanthan gum, sodium carboxy methyl cellulose, benzyl alcohol, sodium benzoate, baking soda, sodium saccharin, titanium dioxide, polyethylene glycol 400, FD&C blue #1
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SPL UNCLASSIFIED SECTION
TWO 3.5 OZ (99 g) TUBES • TOTAL NET WT 7 OZ (198 g)
VALUE 2 PACK
FIGHTS TARTAR AND HELPS WHITEN TEETH*
WITH BAKING SODA
COOL MINT
CAVITIES TARTAR
PLAQUE BREATH
ENAMEL WHITENS
*HELPS WHITEN TEETH WITH REGULAR BRUSHING TWICE A DAY
DESIGNED IN U.S.A. • MADE IN INDIA
Brush Buddies®
WWW.BRUSHBUDDIES.COM
QUESTIONS OR COMMENTS?
1-877-274-8358 TOLL FREE IN USA
1-909-434-0911 INTERNATIONALPATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE
DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761
- Packaging
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INGREDIENTS AND APPEARANCE
BRUSH BUDDIES VALUE 2 PACK WHITENING
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70108-030 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM SILICATE (UNII: IJF18F77L3) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) XANTHAN GUM (UNII: TTV12P4NEE) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color blue (Light blue) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70108-030-01 2 in 1 BOX 12/15/2019 1 99 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 final part355 12/15/2019 Labeler - Ashtel Studios, Inc (148689180)
