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Drug Facts
Simply White Paste, Dentifrice
FDA Label NDC 51009-248
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tom's Of Maine, Inc. for the product Simply White (NDC 51009-248). 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 other, active ingredient, purpose, use, otc - keep out of reach of children, otc - stop use, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
Purpose
Anticavity
Use
helps protect against cavities
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Otc - Stop Use
If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).
Directions
| adults and children 2 years of age and older | brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician |
| children 2 to 6 years | use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) |
| children under 2 years | ask a dentist or physician |
Inactive Ingredients
hydrated silica, water, sorbitol, glycerin, xylitol, sodium lauryl sulfate, Mentha piperita (peppermint) oil and other natural flavors, xanthan gum, titanium dioxide, Chondrus crispus (carrageenan), sodium hydroxide.
Questions?
1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5 p.m. ET
Principal Display Panel 133 G Carton
SINCE 1970
Tom's
OF MAINE ®
ADA
Accepted
American
Dental
Association ®
clinically proven | natural
SIMPLY WHITE®
whitening | cavity protection
fluoride toothpaste
clean mint
NET WT 4.7 OZ (133 g)
Principal Display Panel 133 G Carton (Clean 01)
* Please review the disclaimer below.
