CREST PREMIUM PLUS ADVANCED WHITENING ACTIVE FOAM- sodium fluoride paste, dentifrice

Crest Premium Plus by

Drug Labeling and Warnings

Crest Premium Plus 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 - 204 g Tube Carton

Crest plus Premium with flip cap

NET WT 5.2 OZ (147 g)

ANTICAVITY FLUORIDE TOOTHPASTE

ACTIVE FOAM

ADVANCED

WHITENING

REMOVES 5X MORE STAINS

CLEAN MINT

INGREDIENTS AND APPEARANCE

CREST PREMIUM PLUS  ADVANCED WHITENING ACTIVE FOAM
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-993
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-993-72	1 in 1 CARTON	01/01/2021
1		204 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 37000-993-52	1 in 1 CARTON	01/01/2021
2		147 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 37000-993-35	3 in 1 CARTON	01/01/2021	01/01/2023
3		147 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	01/01/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)