CLOSE UP FRESHENING WITH MOUTHWASH- sodium fluoride gel, dentifrice

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Drug Labeling and Warnings

CLOSE UP 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

KEEP OUT OF REACH OF CHILDREN

Warnings
Keep out of reach of children under 6 years of age .

WARNINGS

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

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  sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, red 33, red 40.

QUESTIONS

Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET

Principal Display Panel

Anticavity Fluoride Toothpaste

CLOSE UP

with

Ultra



Cinnamon



Flavor Blast



Cleans, Whitens and Freshens

FRESHENING GEL

with Mouthwash

NET WT. 6.0 OZ. (170g)

INGREDIENTS AND APPEARANCE

CLOSE UP  FRESHENING WITH MOUTHWASH
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-644
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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALCOHOL (UNII: 3K9958V90M)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CINNAMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-644-40	1 in 1 CARTON	03/01/2001
1		113.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-644-60	1 in 1 CARTON	03/01/2001
2		170 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10237-644-72	1 in 1 CARTON	03/01/2001	10/14/2019
3		204 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 10237-644-80	1 in 1 CARTON	03/01/2001
4		226.8 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	03/01/2001

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-644)