Label: REXALL TRAVEL TOOTHBRUSH AND TOOTH-PASTE- sodium monofluorophosphate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 55910-087-01 - Packager: Old East Main CO.
- 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 November 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Inactive ingredients:
- Use
- Warnings:
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Directions
• Adults and children 2 years of age & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• Children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing to minimize swallowing
• Children under 2 years: ask a dentist or physician. - Questions or comments?
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SPL UNCLASSIFIED SECTION
Conforms to airline carry-on regulations
TO ASSEMBLE TOOTHBRUSH:
Insert plug end of toothbrush into handle for use.
Insert brush end of toothbrush into handle for storage.Visit us at : Rexall.com
Since 1903 Rexall™ is a Trademark of Rexall Sundown, Inc.
DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072MADE IN INDIA
- Packaging
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INGREDIENTS AND APPEARANCE
REXALL TRAVEL TOOTHBRUSH AND TOOTH-PASTE
sodium monofluorophosphate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-087 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-087-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 10/12/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 24 g Part 1 of 1 REXALL CAVITY PROTECTION TOOTH-PASTE
sodium monofluorophosphate paste, dentifriceProduct Information Item Code (Source) NDC:55910-090 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.3 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM BENZOATE (UNII: OJ245FE5EU) BENZYL ALCOHOL (UNII: LKG8494WBH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 24 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 10/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/12/2022 Labeler - Old East Main CO. (068331990) Registrant - Ashtel Studios, Inc. (148689180)
