FRESHENUP FLUORIDE COOL MINT- sodium monofluorophosphate paste, dentifrice

Freshenup Fluoride Cool Mint by

Drug Labeling and Warnings

Freshenup Fluoride Cool Mint by is a Otc medication manufactured, distributed, or labeled by U. S. Nonwovens Corp, Dabur India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (Total Fluoride Content - 1000 ppm approx)

Purpose

Anticavity

Use

regular brushing with fluoride toothpaste helps protect teeth against cavities

Warnings

Keep out of the reach of children

Keep out of the reach of children under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

• adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician
• children under 6 years: to minimize swallowing use a pea sized amount and supervise brushing until good habits are established
• children under 2 years: ask a dentist or physician

Inactive ingredients

Calcium Carbonate, Sorbitol, Aqua, Silica, Sodium Lauryl Sulphate, Flavour, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate

SPL UNCLASSIFIED SECTION

freshenup​ is a licensed trademark of healthy+KIND Co. Made In India. All rights reserved

PRINCIPAL DISPLAY PANEL

NDC: 52553-052-02

ANTICAVITY

Freshenup

FLUORIDE TOOTHPASTE

COOL MINT

SENSITIVE + GENTLE

ENAMEL STRENGTH

Fresh Breath

Strengthen Against Acids

Gentle Whitening

NET WT 3.5 OZ (99.2 g)

INGREDIENTS AND APPEARANCE

FRESHENUP FLUORIDE COOL MINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52553-052
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52553-052-02	1 in 1 CARTON	08/14/2019
1		99.2 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 not final	part356	08/14/2019

Labeler - U. S. Nonwovens Corp (847061520)

Registrant - U. S. Nonwovens Corp (847061520)

Establishment
Name	Address	ID/FEI	Business Operations
Dabur India Limited		650599231	manufacture(52553-052)