TRULY RADIANT REJUVENATING WHITENING- sodium fluoride 0.243% paste, dentifrice

Truly Radiant Rejuvenating by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Fluoride 0.243%

PURPOSE

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 accidentally 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 - as a dentist or physician

INACTIVE INGREDIENT

Inactive ingredients sodium bicarbonate (baking soda), hydrated silica, sorbitol, water, glycerin, tetrasodium pyrophosphate, sodium lauroly sarcosinate, flavor, sodium saccharin, cellulose gum, sodium lauryl sulfate, mica, titanium dioxide, blue 1, yellow 5

QUESTIONS

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

Principl Display AHFC-00016-01

ARM AND HAMMER

THE STANDARD OF PURITY

Crisp Mint Twist NATURALLY POWERED BY BAKING SODA FLUORIDE ANTICAVITY TOOTHPASTE

Rejuvenating

Truly Radiant

HELPS PREVENT STAINS ENAMEL SAFE WHITENING NEUTRALIZES ACID

NET WT.

4.3OZ (121g)

INGREDIENTS AND APPEARANCE

TRULY RADIANT REJUVENATING  WHITENING
sodium fluoride 0.243% paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-664
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
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

Product Characteristics
Color	blue (with Blue Twist)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-664-43	1 in 1 CARTON	01/05/2015
1		121 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-664-09	1 in 1 CARTON	02/02/2015	10/01/2019
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	01/01/2015

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-664)