ENAMEL DEFENSE- sodium fluoride paste, dentifrice

Enamel Defense by

Drug Labeling and Warnings

Enamel Defense by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Fluoride 0.24%

PURPOSE

Anticavity toothpaste

INDICATIONS & USAGE

Use

aids in the prevention of dental decay

WARNINGS

Warnings

Do not use if irritation occurs and persists.

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

QUESTIONS

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

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)

INGREDIENTS AND APPEARANCE

ENAMEL DEFENSE 
sodium fluoride paste, dentifrice

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
MICA (UNII: V8A1AW0880)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CALCIUM SULFATE (UNII: WAT0DDB505)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
SODIUM CARBONATE (UNII: 45P3261C7T)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-666-43	1 in 1 CARTON	04/01/2020
1		121 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-666-09	1 in 1 CARTON	04/01/2020
2		25 g in 1 TUBE; Type 0: Not a Combination Product

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	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-666)