DR. FRESH TRAVEL- sodium monofluorophosphate paste, dentifrice
Dr. Fresh, LLC

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.

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Dr. Fresh Travel Kit

Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity

Use:

helps protect against cavities.

Warnings

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

Keep out of reach of children

under 6 years of age.

Inactive Ingredients

Calcium Carbonate, Carboxymethyl Cellulose, Flavor, Glycerin, Hydrated Silica, Sodium Benzoate, Sodium Lauryl Sulphate, Sodium Saccharin, Sorbitol, Tetrasodium Pyrophosphate, Water.

Directions: Adults and children 2 years of age and older:
brush teeth thoroughly after meals or at least twice a day as directed by a dentist or physician. 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: ask a dentist.

For clean and healthy teeth: See your dentist on a regular basis for a professional cleaning. Use dental floss daily.

Questions or Comments?

Call toll-free 1-866-373-7374 or visit us at www.drfresh.com and www.binaca.com

Made in Malaysia in a GMP Certified Facility

Distributed by:
Dr. fresh

USA - Dr. Fresh Inc.,
Buena Park, CA 90620 USA

Canada - Dr. Fresh Inc.,
Ontario, Canada L7C2T4

UK - Grosvenor Consumer Products Limited
25 Gore Road
Burnham, Bucks SL1 8AB

Brand Trusted Since 1890

Dr. Fresh Travel Kit
Soft

•: Toothbrush
•: Binaca Toothpaste
•: Toothbrush Cover
•: Reusable Bag

A Binaca Blast that lasts

Binaca
Anticavity Flouride Toothpaste

Peppermint

NET WT. .85 OZ (24g)

Package Labeling - Toothpaste

Product Labeling - Kit

DR. FRESH TRAVEL
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-413
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	076 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-413-00	1 in 1 BOX	12/01/2011	01/31/2014
1		24 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	12/01/2011	01/31/2014

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: 5c5e6336-b522-4cec-86ef-b99ebcdf63a9

Set id: 0f2571b8-2309-4366-b1fb-5e26f6c9ea5c

Version: 3

Effective Time: 20210922

Dr. Fresh, LLC