Clinpro 5000
Approved
Approval ID
f982709b-c486-43a8-b17c-6957092e8f3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2024
Manufacturers
FDA
Solventum US OpCo LLC
DUNS: 801390852
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 Code48878-3120
Product Classification
G
Generic Name
sodium fluoride
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2024
FDA Product Classification
INGREDIENTS (11)
sodium fluorideActive
Quantity: 5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Tricalcium PhosphateInactive
Code: K4C08XP666
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Carboxymethylcellulose SodiumInactive
Code: K679OBS311
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/1/2024
Principal Display Panel – AU/NZ Tube Label
PHARMACIST ONLY MEDICINE
KEEP OUT OF REACH OF CHILDREN
3M
Clinpro™ 5000
Sodium Fluoride 1.1% w/w
Vanilla Mint
Anti-Cavity Toothpaste
For use after professional recommendation.
NET WT 113g
AUST R 219455
