CREST 3D WHITE ARCTIC FRESH- 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

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

3 BENEFITS IN 1

Crest®

3D WHITE™

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT

6.4 OZ (181 g)

ENAMEL SAFE WHITENING

REMOVES UP TO 80%

OF SURFACE STAINS.

ARCTIC FRESH

INGREDIENTS AND APPEARANCE

CREST 3D WHITE  ARCTIC FRESH
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-875
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
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
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)

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: 37000-875-03	1 in 1 CARTON	01/18/2016	12/01/2021
1		99 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-875-04	1 in 1 CARTON	01/18/2016	12/01/2021
2		136 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-875-06	1 in 1 CARTON	01/18/2016	12/01/2021
3		181 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 37000-875-07	1 in 1 CARTON	06/01/2016	09/16/2019
4		198 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 37000-875-08	2 in 1 CARTON	01/18/2016	12/01/2021
5		99 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 37000-875-10	2 in 1 CARTON	01/18/2016	12/01/2021
6		136 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 37000-875-42	119 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/04/2018	12/01/2021
8	NDC: 37000-875-15	3 in 1 CELLO PACK	01/18/2016	12/01/2021
8		1 in 1 CARTON
8		136 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 37000-875-99	3 in 1 CELLO PACK	01/18/2016
9		1 in 1 CARTON
9		116 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 37000-875-82	2 in 1 CELLO PACK	01/18/2016
10		1 in 1 CARTON
10		116 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC: 37000-875-30	1 in 1 CARTON	01/18/2016
11		85 g in 1 TUBE; Type 0: Not a Combination Product
12	NDC: 37000-875-41	1 in 1 CARTON	01/18/2016
12		116 g in 1 TUBE; Type 0: Not a Combination Product
13	NDC: 37000-875-54	1 in 1 CARTON	01/18/2016
13		153 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)