Aquafresh

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:36:53

Label at a glance#

ProductAquafresh Kids Cavity Protection
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

• adults and children 2 years and older: o apply toothpaste onto a toothbrush. o 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. o to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are es...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.84% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

When using this product,

OTC - WHEN USING SECTION

if irritation occurs discontinue use.

Keep out of the reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • Do not store above 25°C (77°F)

Inactive ingredients (bubble mint)

INACTIVE INGREDIENT SECTION

water, sorbitol, calcium carbonate, hydrated silica, glycerin, PEG-8, flavor, titanium dioxide, sodium lauryl sulfate, cellulose gum, sodium bicarbonate, sodium saccharin, calcium carrageenan, red 30, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-897-5623

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0619-01

Aquafresh®

Fluoride Toothpaste

kids

Cavity Protection

2+ years

Sugar Acid Protection **

From Fluoride

BUBBLE MINT

ADA Accepted

American Dental Association®

NET WT 4.6 OZ (130.4 g)

Aquafresh toothpaste fights cavities with fluoride...

freshens breath...

and has a great bubble mint taste, in one complete toothpaste.

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

ALWAYS FOLLOW THE LABEL

This product contains no sugar, like all ADA-accepted toothpastes.

Helps prevent cavities.

Note: If pump doesn't work, hold button down and firmly push up inside base.

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

©2015 GSK or its licensor

105855XB

105855XB_Aquafresh Kids_4.6 oz.JPG
105855XB_Aquafresh Kids_4.6 oz.JPG

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06190135-0619-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3245e318-c550-63af-e063-6294a90ab6e06ec04957-df13-498a-83a4-62dc6d2121372025-04-08WarningsExact identifier
spl set id: 6ec04957-df13-498a-83a4-62dc6d212137

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.