Arm & Hammer Enamel Defense Fluoride Anticavity Toothpaste

Arm & Hammer Enamel Defense Fluoride Anticavity Toothpaste
SPL v3
SPL
SPL Set ID 9e8f1ce9-b161-50db-e053-2995a90ad32b
Route
DENTAL
Published
Effective Date 2023-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 mg)
Inactive Ingredients
Methyl Salicylate Mica Polyethylene Glycol 400 Sodium Lauryl Sulfate Glycerin Sodium Bicarbonate Hydrated Silica Calcium Sulfate, Unspecified Form Saccharin Sodium Dibasic Potassium Phosphate Peg/ppg-116/66 Copolymer Sodium Carbonate Calcium Peroxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Sodium Fluoride 0.24%


Medication Information

Warnings and Precautions

Warnings

Do not use ifirritation occurs and persists.

Indications and Usage

Use

aids in the prevention of dental decay

Dosage and 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

Description

Sodium Fluoride 0.24%

Section 50565-1

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.

Section 51727-6

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

Section 51945-4

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)

Section 53413-1

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

Section 55105-1

Anticavity toothpaste

Section 55106-9

Sodium Fluoride 0.24%


Structured Label Content

Indications and Usage (34067-9)

Use

aids in the prevention of dental decay

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Do not use ifirritation occurs and persists.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Anticavity toothpaste

Section 55106-9 (55106-9)

Sodium Fluoride 0.24%


Advanced Ingredient Data


Raw Label Data

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