ADVANCE WHITE EXTREME WHITENING TARTAR CONTROL- sodium fluoride paste, dentifrice

Advance White Extreme Whitening by

Drug Labeling and Warnings

Advance White Extreme Whitening 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

Active ingredients        

Sodium fluoride (0.24%)

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 throughly 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

Inactive ingredients   sodium bicarbonate, PEG-8, tetrasodium pyrophosphate,PEG/PPG-116/66 copolymer, sodium carbonate peroxide, silica, sodium saccharin, flavor, water, sodium lauroyl sarcosinate, sodium lauryl sulfate

QUESTIONS

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

Principal Display Panel

ARM AND HAMMER The Standard of Purity

Clean Mint NATURALLY POWERED BY BAKING SODA Fluoride Anticavity Toothpaste

AdvanceWhite

EXTREME WHITENING STAIN DEFENSE

BAKING SODA AND PEROXIDE NEUTRALIZES ACID

NET WT. 6.0 OZ. (170g)

INGREDIENTS AND APPEARANCE

ADVANCE WHITE EXTREME WHITENING   TARTAR CONTROL
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-658
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLOXALENE (UNII: V8B3K56SW0)
SODIUM PERCARBONATE (UNII: Z7G82NV92P)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-658-09	1 in 1 CARTON	01/29/2012
1		25 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-658-43	1 in 1 CARTON	01/29/2012
2		121 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10237-658-60	1 in 1 CARTON	01/29/2012
3		170 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 10237-658-72	1 in 1 CARTON	01/29/2012
4		204 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 10237-658-12	2 in 1 CARTON	09/23/2019
5		340 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	01/29/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-658)