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Drug Facts
Cavity Protection
FDA Label NDC 51009-116
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 Cavity Protection (NDC 51009-116). 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, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium monofluorophosphate 0.76% (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.
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
calcium carbonate, water, glycerin, sodium bicarbonate, Chondrus crispus (carrageenan), Mentha piperita (peppermint) oil, xylitol, sodium lauryl sulfate.
Questions?
1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET
Principal Display Panel - 155.9 G Carton
SINCE 1970
Tom's
OF MAINE™
baking soda ∣ natural
CAVITY PROTECTION
fights cavities ∣ fresh breath
fluoride toothpaste
peppermint
ADA
Accepted
American
Dental
Association ®
NET WT 5.5 OZ (155.9 g)
Principal Display Panel (155.9 g Carton)
SINCE 1970
Tom's
OF MAINE™
natural
CAVITY PROTECTION
fights cavities ∣ fresh breath
fluoride toothpaste
spearmint
ADA
Accepted
American
Dental
Association ®
NET WT 5.5 OZ (155.9 g)
Principal Display Panel (155.9 g Carton)
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