Active Ingredient (Cavity Protection, Extra Fresh +Whitening, Multi Action Whitening)
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Aquafresh
FDA Label NDC 0135-0592
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Aquafresh (NDC 0135-0592). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (cavity protection, extra fresh +whitening, multi action whitening), active ingredient (ultimate white), purpose, use, when using this product,, keep out of reach of children under 6 years of age., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (Ultimate White)
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
When Using This Product,
if irritation occurs discontinue use
Keep Out Of Reach Of Children Under 6 Years Of Age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years and older:
- apply toothpaste onto a toothbrush
- brush teeth thoroughly, preferably after each meal, or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
- to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
- children under 2 years of age: Consult a dentist or doctor
Other Information
- store below 30°C (86°F)
Inactive Ingredients (Cavity Protection)
water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1
Inactive Ingredients (Extra Fresh +Whitening)
water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1
Inactive Ingredients (Multi Action Whitening)
water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, red 30, blue 1
Inactive Ingredients (Ultimate White)
water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium saccharin, red 30, blue 1
Questions
Call toll-free 1-800-897-5623
Principal Display Panel
NDC 0135-0590-01
- healthy gums*
- strong teeth
- fresh breath
- healthy gums*
- strong teeth
- fresh breath
fluoride toothpaste
triple protection®
cavity protection
Sugar Acid Protection**
from Fluoride
cool mint
NET WT 5.6 OZ (158.8 g)
**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.
*with twice daily brushing
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed to the GSK group of companies.
©2015 GSK group of companies or its licensor. All rights reserved.
GSK Consumer Healthcare
Warren, NJ 07059
Made in Taiwan
1-800-897-5623
105263XA
NDC 0135-0591-01
fluoride toothpaste
triple protection®
extra fresh +whitening
Sugar Acid Protection**
from Fluoride
fresh mint
NET WT 5.6 OZ (158.8 g)
**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.
*with twice daily brushing
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed to the GSK group of companies.
©2015 GSK group of companies or its licensor. All rights reserved.
GSK Consumer Healthcare
Warren, NJ 07059
1-800-897-5623
105282XA
NDC 0135-0594-01
fluoride toothpaste
triple protection®
WHITENING
MULTI ACTION
Sugar Acid Protection**
from Fluoride
NET WT 5.6 OZ (158.8 g)
cavity protection
healthy gums*
breath
great taste
whitening†
enamel
Invigorating Mint
cavity protection
healthy gums*
fresh breath
great taste
removes surface stains
enamel strengthening
**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shidl that protects the tooth surface against sugar acid attack.
*with twice daily brushing
†whitens by removing surface stains
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed to the GSK group of companies.
©2015 GSK group of companies or its licensor. All rights reserved.
GSK Consumer Healthcare
Warren, NJ 07059
105384XA
NDC 0135-0592-01
fluoride toothpaste
triple protection®
ultimate white
Sugar Acid Protection**
from Fluoride
with whitening action
frost mint
NET WT
6.0 OZ (170.1 g)
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed to the GSK group of companies.
©2015 GSK group of companies or its licensor. All rights reserved.
GSK Consumer Healthcare, Warren, NJ 07059
105287XA
* Please review the disclaimer below.
