Wentworth Alcohol Free (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 473 mL Rinse Label

NDC 11527-735-16

Wentworth^®

AlCOHOL FREE

Sodium Fluoride Rinse

0.2% Neutral Sodium Fluoride

Reduces cari es up to 55%¹

COOL MINT

KEEP OUT OF REACH OF INFANTS AND CHILDREN

16 FL OZ (1 PT) 473 mL

Rx ONLY

PRINCIPAL DISPLAY PANEL — 473 mL Carton Label

NDC 11527-735-16

Wentworth^®

AlCOHOL FREE

Sodium Fluoride Rinse

0.2% Neutral Sodium Fluoride

Reduces cari es up to 55%¹

COOL MINT

KEEP OUT OF REACH OF INFANTS AND CHILDREN

16 FL OZ (1 PT) 473 mL

Rx ONLY

WENTWORTH ALCOHOL FREE sodium fluoride mouthwash

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11527-735 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.9 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZOIC ACID GLYCERIN POLOXAMER 338 PROPYLENE GLYCOL SODIUM BENZOATE WATER FD&C BLUE NO. 1

Product Characteristics Color BLUE (A clear blue solution) Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:11527-735-16 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 473 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (11527-735-16)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/15/2021

Labeler — Sheffield Pharmaceuticals LLC (151177797)

Registrant — Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture (11527-735), analysis (11527-735)

Revised: 03/2021 Sheffield Pharmaceuticals LLC