TRULY RADIANT WHITENING AND STRENGTHENING RINSE CLEAN AND FRESH- sodium fluoride 0.02% liquid

Truly Radiant by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts Truly Radiant Fluoride Rinse

Active ingredient

Sodium Fluoride 0.02%

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Uses

Aids in the prevention of dental cavities

WARNINGS

Warnings

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

Adults and children 6 years of age and older

• use twice a day after brushing your teeth with a toothpaste
• vigorously swish 10mL (2 teaspoons) of rinse between your teeth for a least 1 minue then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary until capable of using without supervision

Children under 6 years of age consult a dentist or doctor

OTHER SAFETY INFORMATION

Other Information

• do not use if safety seal is broken or missing

INACTIVE INGREDIENT

Inactive ingredients water, sorbitol, glycerin, propylene glycol, polysorbate 20, poloxamer 407, tetrasodium pyrophosphate, sodium lauryl sulfate, sodium bicarbonate (baking soda), disodium pyrophosphate, flavor, xylitol, sodium saccharin, d&c green 5, d&c red 33

QUESTIONS

Questions or commentscall us at 1–800–786-5135 M–F 9am–5pm ET or visit our website atwww.TrulyRadiant.com

Truly Radiant Whitening & Strengthening Fluoride Rinse

Alcohol Free

Truly Radiant

Whitening & Strengthening Fluoride Rinse

CLEAN & FRESH

WHITER SMILE IN JUST 5 DAYS*

Plus Micro-Cleansers & Lasting Freshness

• PEROXIDE-FREE Whitening
• Fights Cavities & Strengthens Enamel
• Cleans Where Brushing May Miss

CLEAN MINT

16 FL OZ (473 mL)

Label AHLBFB-00119-01.jpg

INGREDIENTS AND APPEARANCE

TRULY RADIANT  WHITENING AND STRENGTHENING RINSE CLEAN AND FRESH
sodium fluoride 0.02% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62864-665
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62864-665-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 62864-665-08	237 mL in 1 BOTTLE; 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	10/02/2015

Labeler - Church & Dwight Canada Corp (253933600)

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp.		253933600	manufacture(62864-665)