COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE- sodium fluoride rinse

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

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Team Technologies, Inc.
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity aids in the prevention of dental cavities
Authorization status:
OTC monograph final
Authorization number:
67659-034-30

COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING

GRAPE FLUORIDE- sodium fluoride rinse

Team Technologies, Inc.

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.

----------

Colgate

Phos-Flur

Ortho Defense

Alcohol Free Anticavity Gushing Grape Fluoride Rinse

Drug Facts

Active ingredient

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

Purpos e

Anticavity

Us e

aids in the prevention of dental cavities

Warnings

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical

help or contact a Poison Control Center right away.

Directions

adults and

children 6 years

of age and older

use once a day after brushing your teeth with a

toothpaste

vigorously swish 10 milliliters (10 mL mark on

cap or 2 teaspoonfuls) of rinse between your teeth

for 1 minute then spit out

do not swallow the rinse

do not eat or drink for 30 minutes after rinsing

instruct children under 12 years of age in good

rinsing habits (to minimize swallowing)

supervise children as necessary until capable of

using without supervision

children under 6

years of age

ask a dentist or physician

Inactive ingredients

water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C

blue no. 1, FD&C red no. 40

Other Information

®

®

®

store at controlled room temperature 68 – 77° F (20 – 25°C)

Ques tions ?

1-800-468-6502

Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE*

Colgate

PhosFlur

Ortho Defense

Anticavity Fluoride Rinse

IDEAL PROTECTION

WHILE WEARING BRACES

1. ORTHODONTIST RECOMMENDED

2. HELPS STRENGTHEN ENAMEL

3. HELPS PREVENT CAVITIES

GUSHING GRAPE

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT: Read directions for proper use

ADA

Accepted

American

Dental

Association

P9895933

Phos Flur Artwork

®

®

®

®

COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY

GUSHING GRAPE FLUORIDE

sodium fluoride rinse

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 76 59 -0 34(NDC:0 126 -0 0 34)

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

2 mg in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

Team Technologies, Inc.

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Product Characteristics

Color

purple

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 76 59 -0 34-30

10 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 8 /0 1/20 17

Labeler -

T eam T echnologies, Inc. (192339703)

Registrant -

T eam T echnologies, Inc. (192339703)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Team Techno lo gies, Inc

0 79 3378 0 0

repack(6 76 59 -0 34) , relabel(6 76 59 -0 34)

Revised: 12/2019

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