Otc - Active Ingredient
Sodium Fluoride 0.24%
Enamel Defense Paste, Dentifrice
FDA Label NDC 10237-666
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Enamel Defense (NDC 10237-666). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anticavity toothpaste
Indications & Usage
Use
aids in the prevention of dental decay
Warnings
Warnings
Do not use if irritation occurs and persists.
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 accidently swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- do not swallow
- supervise children as necessary until capable of using without supervision
- rinse away toothpaste residue thoroughly after brushing
adults and children 2 years and older - brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years - instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years - ask a dentist or physician
Inactive Ingredient
sodium bicarbonate (baking soda), PEG-8, hydrated silica, glycerin, calcium sulfate, sodium lauryl sulfate, sodium saccharin, flavor, dipotassium phosphate, PEG/PPG 116/66 copolymer, sodium carbonate, calcium peroxide, mica, titanium dioxide
Otc - Questions
Questions or comments? Call 1-800-786-5135 Mon.-Fri. 9am-5pm ET or visit www.myoralcare.com
Package Label.Principal Display Panel
ARM & HAMMER
THE STANDARD OF PURITY
Enamel Defense
Fluoride Anticavity Toothpaste
formerly known as BRIGHT & STRONG
REPAIRS AND PROTECTS ENAMEL SURFACE
Crisp Mint
NET WT 4.3 OZ. (121g)
Lo_s01686c_2048783_r6 (Lo S01686c 2048783 R6)
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