MedPath

Crest

Crest® Bubblegum

Approved
Approval ID

7d628f5b-f5f7-7c85-e053-2a91aa0a99cc

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Procter & Gamble Manufacturing México, S. de R.L. de C.V.

DUNS: 812807550

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58933-174
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (11)

SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CARBOXYPOLYMETHYLENEInactive
Code: 0A5MM307FC
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PHOSPHATEInactive
Code: SE337SVY37
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1.5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/18/2018

PRINCIPAL DISPLAY PANEL - 119 g Tube

**3+**YRS
Crest ®

FLUORIDE ANTICAVITY TOOTHPASTE

Disney

Encanto

BUBBLEGUM

NET WT 4.2 OZ (119 g)

artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/12/2012

Use

helps protect against cavities

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/1/2018

Inactive ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, sodium phosphate, cellulose gum, flavor, sodium saccharin, carbomer, red 28

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/18/2018

Questions?

1-800-492-7378

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/18/2018

Directions

  • twist off cap to remove foil seal
  • 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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/18/2018

MADE IN MEXICO
DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/12/2012

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/12/2012

Purpose

Anticavity toothpaste

WARNINGS SECTION

LOINC: 34071-1Updated: 1/12/2012

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.

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Crest - FDA Drug Approval Details