CREST 3D WHITE RADIANT MINT- sodium fluoride paste, dentifrice

Crest 3D White by

Drug Labeling and Warnings

Crest 3D White by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Warning

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

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, sodium saccharin, carbomer, polysorbate 80, mica, titanium dioxide, blue 1

Questions?

1-800-492-7378

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DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

IMPROVED FORMULA

Crest ®

3D WHITE™
FLUORIDE ANTICAVITY TOOTHPASTE

NET WT
3.0 OZ (85 g)
ENAMEL SAFE WHITENING

Removes up to 80 % of surface stains

EVEN IN HARD TO REACH PLACES

RADIANT MINT

INGREDIENTS AND APPEARANCE

CREST 3D WHITE  RADIANT MINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-876
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
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-876-01	1 in 1 CARTON	01/18/2016
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-876-02	1 in 1 CARTON	01/18/2016	12/01/2021
2		70 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-876-03	1 in 1 CARTON	01/18/2016	12/01/2021
3		99 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 37000-876-04	1 in 1 CARTON	01/18/2016	12/01/2021
4		136 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 37000-876-05	1 in 1 CARTON	02/05/2018
5		153 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 37000-876-07	2 in 1 CARTON	01/18/2016	12/01/2021
6		99 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 37000-876-10	2 in 1 CARTON	01/18/2016	12/01/2021
7		136 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 37000-876-12	1 in 1 CARTON	01/18/2016	12/31/2018
8		34 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 37000-876-82	2 in 1 CELLO PACK	07/01/2019
9		1 in 1 CARTON
9		116 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 37000-876-15	3 in 1 CELLO PACK	01/18/2016	12/01/2021
10		1 in 1 CARTON
10		136 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC: 37000-876-30	1 in 1 CARTON	07/01/2019
11		85 g in 1 TUBE; Type 0: Not a Combination Product
12	NDC: 37000-876-41	1 in 1 CARTON	07/01/2019
12		116 g in 1 TUBE; Type 0: Not a Combination Product
13	NDC: 37000-876-99	3 in 1 CELLO PACK	07/01/2019
13		1 in 1 CARTON
13		116 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	01/18/2016

Labeler - The Procter & Gamble Manufacturing Company (004238200)