MedPath

Kids Crest Cavity Protection

Kid's Crest Cavity Protection Sparkle Fun

Approved
Approval ID

df182c22-bbf1-448d-81e8-35cb431d2afc

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 Code58933-049
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)

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
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1.5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
SORBITOLInactive
Code: 506T60A25R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/21/2012

PRINCIPAL DISPLAY PANEL - 76.5 g Tube in Carton Label

KID'S
** CREST**®

CAVITY
** PROTECTION**

SPARKLE FUN

ADA
** Accepted**
** American**
** Dental**
** Association ®**

FLUORIDE
ANTICAVITY
TOOTHPASTE

NET WT 2.7 OZ (76.5 g)

049

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/27/2017

Use

helps protect against cavities

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/27/2017

Questions?

1-800-492-7378

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/27/2017

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/27/2017

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/27/2017

Purpose

Anticavity toothpaste

WARNINGS SECTION

LOINC: 34071-1Updated: 9/27/2017

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/27/2017

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: 9/27/2017

Inactive ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, sodium phosphate, cellulose gum, flavor, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

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Kids Crest Cavity Protection - FDA Drug Approval Details