FRESHENUP FLUORIDE COOL MINT- sodium monofluorophosphate paste, dentifrice

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)
Available from:
U. S. Nonwovens Corp
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity regular brushing with fluoride toothpaste helps protect teeth against cavities
Authorization status:
OTC monograph not final
Authorization number:
52553-052-02

FRESHENUP FLUORIDE COOL MINT- sodium monofluorophosphate paste, dentifrice

U. S. Nonwovens Corp

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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Freshenup Fluoride Toothpaste

Drug Facts

Active ingredient

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

Purpos e

Anticavity

Us e

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

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)

FRESHENUP FLUORIDE COOL MINT

sodium monofluorophosphate paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:52553-0 52

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

So dium Mo no fluo ro pho spha te (UNII: C8 10 JCZ56 Q) (fluo ride io n - UNII:Q8 0 VPU40 8 O)

fluo ride io n

7.6 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

SO RBITO L (UNII: 50 6 T6 0 A25R)

WATER (UNII: 0 59 QF0 KO0 R)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM SILICATE (UNII: IJF18 F77L3)

SO DIUM PYRO PHO SPHATE (UNII: O3528 6 4B8 Z)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

XANTHAN GUM (UNII: TTV12P4NEE)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:52553-0 52-0 2

1 in 1 CARTON

0 8 /14/20 19

1

9 9 .2 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 8 /14/20 19

Labeler -

U. S. Nonwovens Corp (847061520)

Registrant -

U. S. Nonwovens Corp (847061520)

Establishment

U. S. Nonwovens Corp

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dabur India Limited

6 50 59 9 231

ma nufa c ture (52553-0 52)

Revised: 8/2019

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