Topical 60 Sec Sodium Fluoride
FDA Label NDC 50227-0521

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Patterson Dental Supply Inc for the product Topical 60 Sec Sodium Fluoride (NDC 50227-0521). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications, medical ingredient, non-medical ingredients, warning, storage and handling, other, principal display panel - 125g canister label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications

For topical application to aid in the protection against dental caries.

Medical Ingredient

1.23% Fluoride ion from sodium fluoride.

Non-Medical Ingredients

Sodium saccharin, sodium benzoate, sodium methyl cocoyl taurate, polyethylene glycol 400, cetyl alcohol, Cetyl phosphate (and) Stearic Acid, Oleth-3 Phosphate, heptafluoropropane HFC 227, SDA 38B (benzaldehyde) 200 proof, sodium phosphate monobasic monohydrate, bubble gum flavor.

Warning

Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate.

Storage And Handling

Store between temperatures 55-80°F. Keep from freezing.

Other

Federal (U.S.A.) Law prohibits dispensing without prescription.

Manufactured for:
PATTERSON DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120

MADE IN U.S.A.
Patent Pending

0531152LA, R1-021712

Principal Display Panel - 125G Canister Label

PATTERSON
DENTAL

NDC# 50227-0521-6

60-Second
Foam Fluoride

APF* Topical Fluoride Solution
*Acidulated Phosphate Fluoride
1.23% Fluoride Ion (pH 3.5)

BUBBLE GUM

Caution: For professional use only.
Store at room temperature.
Shake well before each use.

Reorder Number
088-6135

NET WT. 4.4 OZ. (125g)

* Please review the disclaimer below.