SENSODYNE PRONAMEL 6 TO 12 YEARS- sodium fluoride paste 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

Active ingredient

Sodium fluoride 0.25% (0.15 w/v fluoride ion)

Purpose

Anticavity

Uses

aids in the prevention of dental cavities

Warnings

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 of age and older:
apply toothpaste onto a toothbrush
brush teeth thoroughly, preferable 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

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sucralose, titanium dioxide, sodium hydroxide

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0588-02

SENSODYNE

PRONAMEL

FLUORIDE TOOTHPASTE

6-12 years

Gentle Mint

#1 Dentist Recommended Brand*

9 out of 10 dentists recommended brand

NET WT 4.0 OZ (113g)

Helps protect enamel from cavities and everyday acids

Helps protect against the effects of acid erosion

Helps harden tooth enamel

Helps protect against cavities

Developed with dentists

Gentle mint taste

Developed with dentists to help protect children’s teeth from the effects of acid erosion

Everyone recognizes sugar-related tooth decay as a major issue in children’s oral health. However, dentists are increasingly concerned about the effects of acid erosion, caused by acids found in fruits, juices and soft drinks in today’s diet. Most children’s permanent teeth come through between the ages of 6-12. These new teeth along with their baby teeth are vulnerable to attack from acids. These acids soften the enamel, allowing it to be slowly worn away. Once the enamel is gone, it’s gone forever.

Sensodyne® ProNamel® toothpaste for Children is an everyday fluoride toothpaste specially formulated in collaboration with dentists to strengthen the tooth enamel and to help protect your children’s teeth from the effects of acid erosion as well as tooth decay.

Because Sensodyne® ProNamel® toothpaste is specially formulated for children, it does not contain an anti-sensitivity ingredient.

*#1 Dentist Recommended Brand for Protection Against the Effects of Acid Erosion†

†Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel toothpaste has fluoride it helps protect against cavities too.

©2015 GSK group of companies or its licensor. All rights reserved.

ALWAYS FOLLOW THE LABEL

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

SENSODYNE, PRONAMEL and device marks are trademarks owned by or licensed to the GSK group of companies.

104903XA

Sensodyne Pronamel 6 to 12 Years 4.0 oz (113 g) carton
SENSODYNE PRONAMEL  6 TO 12 YEARS
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0588
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0588-011 in 1 CARTON12/21/201505/31/2018
123 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0588-021 in 1 CARTON12/21/201505/31/2018
2113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/21/201505/31/2018
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 3/2018
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC