REXALL TRAVEL TOOTHBRUSH AND TOOTH-PASTE- sodium monofluorophosphate kit

Rexall Travel Toothbrush and Tooth-paste by

Drug Labeling and Warnings

Rexall Travel Toothbrush and Tooth-paste by is a Otc medication manufactured, distributed, or labeled by Old East Main CO., Ashtel Studios, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76%
(0.13% w/v fluoride ion)

Purpose

Anticavity toothpaste

Inactive ingredients:

Sorbitol, Hydrated Silica, Treated Water (Aqua), Poly Ethylene Glycol 1500 (PEG-32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (CI 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

Use

helps protect against cavities

Warnings:

Keep out of the reach of children under 6 yrs. of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. 

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?

Call toll free 1-866-4-REXALL

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 37072

MADE IN INDIA

Packaging

INGREDIENTS AND APPEARANCE

REXALL TRAVEL TOOTHBRUSH AND TOOTH-PASTE 
sodium monofluorophosphate kit

Product 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, dentifrice

Product 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 Drug	M021	10/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	10/12/2022

Labeler - Old East Main CO. (068331990)

Registrant - Ashtel Studios, Inc. (148689180)