ORAL-B PRO-HEALTH WHITENING TOOTHPASTE tube

Main information

  • Trade name:
  • ORAL-B PRO-HEALTH WHITENING TOOTHPASTE tube
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ORAL-B PRO-HEALTH WHITENING TOOTHPASTE tube
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 194640
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

194640

ORAL-B PRO-HEALTH WHITENING TOOTHPASTE tube

ARTG entry for

Medicine Registered

Sponsor

Procter & Gamble Australia Pty Ltd

Postal Address

Level 4/ 1 Innovation Road,MACQUARIE PARK, NSW, 2113

Australia

ARTG Start Date

16/02/2012

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ORAL-B PRO-HEALTH WHITENING TOOTHPASTE tube

Product Type

Single Medicine Product

Effective date

14/09/2015

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Assists in the prevention of gingivitis. Assists in the treatment of gingivitis. Helps prevent gum problems. Helps build increasing protection against painful

sensitivity. Assists in the management of sensitive teeth. Helps prevent cavities. Helps prevent plaque build-up. Helps freshen breath. Helps prevent

enamel erosion. Antibacterial protection against plaque.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

HDPE

2 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

100g and 145g

Not scheduled. Not considered by committee

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Paste

Route of Administration

Dental

Visual Identification

A blue-green to green gel-like paste with white speckles.

Active Ingredients

sodium fluoride

.0775 % w/w

Stannous fluoride

.454 % w/w

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:10:21 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information