Kids Crest Cavity Protection Sparkle Fun (Sodium Fluoride) Paste, Dentifrice [The Procter & Gamble Manufacturing Company] -

KIDS CREST CAVITY PROTECTION SPARKLE FUN (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC	37000-049-01, 37000-049-02, 37000-049-03, 37000-049-04, 37000-049-05, 37000-049-06, 37000-049-22, 37000-049-42, 37000-049-92
Set ID	126c6f39-0ef7-40ee-b3ba-e56a76739c57
Category	HUMAN OTC DRUG LABEL
Packager	The Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number	PART355

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)
Purpose

Anticavity toothpaste
Use

helps protect against cavities
Warnings

Keep out of reach of children under 6 yrs. of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  - do not swallow
  - to minimize swallowing use a pea-sized amount in children under 6
  - supervise children's brushing until good habits are established
- children under 2 yrs.: ask a dentist
Inactive ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, sodium phosphate, cellulose gum, flavor, sodium saccharin, carbomer, mica, titanium dioxide, blue 1
Questions?

1-800-492-7378
PRINCIPAL DISPLAY PANEL - 76.5 g Tube Carton

KID'S
Crest ®

CAVITY
PROTECTION

ADA
Accepted
American
Dental
Association ®

FLUORIDE ANTICAVITY
TOOTHPASTE

SPARKLE FUN
FLAVOR

NET WT 2.7 OZ (76.5 g)

INGREDIENTS AND APPEARANCE

KIDS CREST CAVITY PROTECTION SPARKLE FUN
sodium fluoride paste, dentifrice

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

Ingredient Name	Strength
Inactive Ingredients
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-049-03	2.5 g in 1 POUCH; Type 0: Not a Combination Product	09/05/2002
2	NDC:37000-049-01	1 in 1 CARTON	09/05/2002
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:37000-049-04	1 in 1 CARTON	09/05/2002	12/19/2016
3		77 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:37000-049-02	1 in 1 CARTON	09/05/2002
4		130 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:37000-049-06	170 g in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2002	12/01/2018
6	NDC:37000-049-05	1 in 1 CARTON	09/05/2002	06/14/2019
6		76 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:37000-049-42	119 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2017
8	NDC:37000-049-92	2 in 1 CELLO PACK	09/05/2002
8		1 in 1 CARTON
8		130 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC:37000-049-22	1 in 1 CARTON	01/07/2019
9		62 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC:37000-049-30	3 in 1 CELLO PACK	01/01/2021
10		1 in 1 CARTON
10		130 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/05/2002

Labeler - The Procter & Gamble Manufacturing Company (004238200)

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