OTC Medication Information: Crest Fresh and White

CREST FRESH AND WHITE- sodium fluoride paste, dentifrice
Procter & Gamble Manufactura, S. de R.L. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate, cellulose gum, sodium saccharin, carbomer, titanium dioxide

Questions?

1-800-492-7378

DISTR. BY
PROCTER & GAMBLE,
CINCINNATI, OH 45202

MADE IN MEXICO

PRINCIPAL DISPLAY PANEL — 82 g Tube Carton

CLEANS & WHITENS TEETH*

Crest ®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 2.9 OZ (82 g)

FRESH AND WHITE

Peppermint
GLEEM ™ Paste

868
(click image for full-size original)
CREST FRESH AND WHITE
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58933-868
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL
WATER
HYDRATED SILICA
SODIUM LAURYL SULFATE
SODIUM PHOSPHATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
SACCHARIN SODIUM
TITANIUM DIOXIDE
Product Characteristics
Color white Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58933-868-02 1 TUBE in 1 CARTON contains a TUBE
1 82 g in 1 TUBE This package is contained within the CARTON (58933-868-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 03/09/2015
Labeler — Procter & Gamble Manufactura, S. de R.L. de C.V. (812807550)

Revised: 09/2019 Procter & Gamble Manufactura, S. de R.L. de C.V.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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