COMPLETE CARE WHOLE MOUTH PROTECTION- sodium fluoride paste, dentifrice

Complete Care Whole Mouth Protection by

Drug Labeling and Warnings

Complete Care Whole Mouth Protection 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

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

PURPOSE

Anticavity toothpaste

INDICATIONS & USAGE

aids in the prevention of dental decay

WARNINGS

Warnings
Do not use if irritation occurs and persists.

Do not useif 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

Directionsdo 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

Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, flavor, sodium lauryl sulfate, sodium lauroyl sarcosinate, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide

QUESTIONS

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

Principal Display Panel

Great

New

Formula!

Anticavity

Fluoride

Toothpaste

ARM AND HAMMER The Standard of Purity

UP TO 3X MORE PLAQUE REMOVAL*

COMPLETE CARE™

whole mouth protection

provides deep cleaning, whitening & gum health

fresh mint

ULTRA

SMOOTH

FORMULA

NET WT. 6.0 OZ. (170g)

INGREDIENTS AND APPEARANCE

COMPLETE CARE WHOLE MOUTH PROTECTION 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-675
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)

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: 10237-675-60	1 in 1 CARTON	12/31/2021
1		170 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-675-09	1 in 1 CARTON	12/31/2021
2		25.5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10237-675-12	1 in 1 CARTON	12/31/2021	02/16/2025
3		340 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 10237-675-62	2 in 1 CARTON	08/24/2023
4		170 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 10237-675-64	4 in 1 PACKAGE	03/04/2022
5		1 in 1 CARTON
5		170 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 Drug	M021	12/31/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-675)