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Crest Tartar Protection

Crest Tartar Protection

Approved
Approval ID

5940711d-71b7-cb7d-e053-2a91aa0aef18

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Procter & Gamble Manufactura, 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 Code58933-008
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 (12)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SODIUM ACID PYROPHOSPHATEInactive
Code: H5WVD9LZUD
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
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: 4/8/2015

PRINCIPAL DISPLAY PANEL - 161 g Tube Carton

HELPS PREVENT TARTAR & CAVITIES

Crest®

ADA


** Accepted******


** American**


** Dental**


** Association****®**

FLUORIDE ANTICAVITY TOOTHPASTE


** NET WT 5.7 OZ (161 g)**

TARTAR


** PROTECTION**

Regular PasteTartar Protection

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/8/2015

Use

helps protect against cavities

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/8/2015

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/8/2015

Purpose

Anticavity toothpaste

WARNINGS SECTION

LOINC: 34071-1Updated: 4/8/2015

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/8/2015

Dist. by Procter & Gamble, Cincinnati, OH 45202

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/8/2015

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 4/8/2015

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/8/2015

Questions?

1-800-492-7378

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Crest Tartar Protection - FDA Drug Approval Details