Truly Radiant Whitening and Enamel Strengthening Toothpaste

Truly Radiant by

Drug Labeling and Warnings

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

Drug Details [pdf]

TRULY RADIANT WHITENING AND ENAMEL STRENGTHENING- sodium fluoride 0.243% 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.

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Truly Radiant Whitening and Enamel Strengthening Toothpaste

Drug Facts

Active ingredient

Sodium Fluoride 0.243%

Purpose

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 accidentally 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 - as a dentist or physician

Inactive ingredients sodium bicarbonate (baking soda), PEG-8, hydrated silica, glycerin, cacium sulfate, sodium lauryl sulfate, sodium saccharin, flavor, potassium phosphate, PEG/PPG 116/66, sodium carbonate, calcium peroxide, mica, titanium dioxide

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

ARM AND HAMMER

THE STANDARD OF PURITY

Crisp Mint

NATURALLY POWERED BY BAKING SODA

Fluoride Anticavity Toothpaste

Bright and Strong

TRULY RADIANT

HELPS REPAIR ENAMEL SURFACE

LIQUID CALCIUM TECHNOLOGY

ENAMEL SAFE WHITENING

NET WT.

0.9 OZ. (25g)

TRULY RADIANT  WHITENING AND ENAMEL STRENGTHENING
sodium fluoride 0.243% paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-663
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CALCIUM SULFATE (UNII: WAT0DDB505)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM CARBONATE (UNII: 45P3261C7T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-663-43	1 in 1 CARTON	01/05/2014	01/29/2020
1		121 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-663-09	1 in 1 CARTON	02/02/2014	01/29/2020
2		25 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10237-663-52	1 in 1 CARTON	01/01/2014	09/29/2019
3		147 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	01/01/2014	01/29/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-663)

Revised: 1/2020

Document Id: 9d49376f-f356-40f2-e053-2995a90ad760

34390-5

Set id: 0e21c699-7485-5f56-e054-00144ff88e88

Version: 7

Effective Time: 20200129