COLGATE ENAMEL HEALTH MOUTHWASH- 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:
Colgate-Palmolive Company
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity aids in the prevention of dental cavities
Authorization status:
OTC monograph final
Authorization number:
35000-728-16, 35000-728-33, 35000-728-84

COLGATE ENAMEL HEALTH MOUTHWASH- sodium fluoride rinse

Colgate-Palmolive Company

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

Enamel Health

Mouthwash

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpos e

Anticavity

Us es

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 twice a day after brushing your teeth with a toothpaste

vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and 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: consult a dentist or doctor

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil,

phosphoric acid, sodium saccharin, cetylpyridinium chloride, disodium phosphate, potassium sorbate,

sucralose, FD&C green no. 3

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 - 1 L Bottle Label

NEW

ALCOHOL FREE

Colgate

Anticavity Fluoride Mouthwash

ENAMEL

HEALTH

STRENGTHENS ENAMEL EVEN

WHERE BRUSHING MAY MISS

WITH FLUORIDE

SPARKLING FRESH MINT

33.8 FL OZ

(1.05 QT)

IMPORTANT:

Read directions

for proper use

P9903598

HELPS REPLENISH NATURAL CALCIUM

BACK INTO ENAMEL

REVERSES ENAMEL SOFTENING TO HELP

PREVENT CAVITIES

FRESHENS BREATH

COLGATE ENAMEL HEALTH MOUTHWASH

sodium fluoride rinse

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:350 0 0 -728

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

0 .1 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

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

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

PO LO XAMER 3 3 8 (UNII: F75JV2T50 5)

SO DIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: 22ADO53M6 F)

PEG-4 0 CASTO R O IL (UNII: 4ERD20 76 EF)

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

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

Colgate-Palmolive Company

Product Characteristics

Color

GREEN

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:350 0 0 -728 -16

50 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 15

2

NDC:350 0 0 -728 -33

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

0 8 /0 1/20 15

3

NDC:350 0 0 -728 -8 4 250 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt355

0 8 /0 1/20 15

Labeler -

Colgate-Palmolive Company (001344381)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co lga te -Pa lmo live

78 50 479 9 9

MANUFACTURE(350 0 0 -728 )

Revised: 12/2019

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