AQUAFRESH KIDS CAVITY PROTECTION- sodium monofluorophosphate paste

Aquafresh by

Drug Labeling and Warnings

Aquafresh by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Anticavity

Use

• aids in the prevention of dental cavities.

Warnings

When using this product,

if irritation occurs discontinue use.

Keep out of the 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

• Do not store above 25°C (77°F)

Inactive ingredients (bubble mint)

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?

Call toll-free 1-800-897-5623

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

INGREDIENTS AND APPEARANCE

AQUAFRESH  KIDS CAVITY PROTECTION
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0619
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARRAGEENAN CALCIUM (UNII: 5C4SQ0541D)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0619-01	130.4 g in 1 CANISTER; Type 0: Not a Combination Product	09/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2017

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)