OTC Medication Information: Enamel Defense

ENAMEL DEFENSE- sodium fluoride paste, dentifrice
Church & Dwight Co., Inc.

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.

Sodium Fluoride 0.24%

Anticavity toothpaste

Use

aids in the prevention of dental decay

Warnings

Do not use if irritation occurs and persists.

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.

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

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

Questions or comments? Call 1-800-786-5135 Mon.-Fri. 9am-5pm ET or visit www.myoralcare.com

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)

ENAMEL DEFENSE sodium fluoride paste, dentifrice

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-666 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.24 mg in 1 g

Inactive Ingredients Ingredient Name Strength METHYL SALICYLATE MICA POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE GLYCERIN SODIUM BICARBONATE HYDRATED SILICA CALCIUM SULFATE SACCHARIN SODIUM POTASSIUM PHOSPHATE, DIBASIC PEG/PPG-116/66 COPOLYMER SODIUM CARBONATE CALCIUM PEROXIDE TITANIUM DIOXIDE

Product Characteristics Color white Score Shape Size Flavor MINT (Crisp Mint) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10237-666-43 1 TUBE in 1 CARTON contains a TUBE 1 121 g in 1 TUBE This package is contained within the CARTON (10237-666-43) 2 NDC:10237-666-09 1 TUBE in 1 CARTON contains a TUBE 2 25 g in 1 TUBE This package is contained within the CARTON (10237-666-09)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/01/2020

Labeler — Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Operations
Church & Dwight Co., Inc.		043690812	manufacture (10237-666)

Revised: 04/2020 Church & Dwight Co., Inc.