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Drug Facts
Clean And Gentle
FDA Label NDC 51009-107
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 Clean And Gentle (NDC 51009-107). 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% (0.13% 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
glycerin, water, calcium carbonate, hydrated silica, organic Aloe barbadensis (aloe) leaf juice, xylitol, Chondrus crispus (carrageenan), Acacia senegal (acacia) gum, glycyrrhizic acid, Mentha piperita (peppermint) oil.
Questions?
1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET
Principal Display Panel - 133 G Carton
SINCE 1970
Tom's
OF MAINE™
with fluoride | natural
CLEAN & GENTLE
SLS-free | anticavity | whitening | fresh breath
fluoride toothpaste
peppermint
NET WT 4.7 OZ (133 g)
Principal Display Panel (133 g Carton)
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