MedPath

Crest 3D White

Crest 3D White Advanced Radiant Mint

Approved
Approval ID

f5c89efc-5fa0-2a05-e053-2a95a90a7b9c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 2, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

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 Code69423-770
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateMay 2, 2025
FDA Product Classification

INGREDIENTS (14)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARBOXYPOLYMETHYLENEInactive
Code: 0A5MM307FC
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Code: P1BM4ZH95L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 1.5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT

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Crest 3D White - FDA Drug Approval Details