Tovet (emollient Formulation) (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 100 g Canister Carton

Rx Only

NDC 43538-952-10

Tovet_®
(clobetasol propionate)
Foam, 0.05%

Emollient
Formulation

For Topical Use Only.

Not For Ophthalmic, Oral,
or Intravaginal Use.

100 g

MEDIMETRIKS PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC 43538-953-10
Rx Only

Tovet_®
(clobetasol propionate)
Foam, 0.05%
KIT

Emollient Formulation

For Topical Use Only.

Not For Ophthalmic, Oral,
or Intravaginal Use.

KIT CONTENTS:
1 — Tovet® (clobetasol propionate) Foam, 0.05% — 100g
1 — Keradan^® Cream — Net wt. 9 oz. (255 g) Tube

MEDIMETRIKS PHARMACEUTICALS, INC.

Established Pharmacological Class

Substance Pharmacological Class Keradan MOISTURIZING

TOVET (EMOLLIENT FORMULATION) clobetasol propionate aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-952 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength cetyl alcohol ANHYDROUS CITRIC ACID cyclomethicone glycerin isopropyl myristate polyoxyl 20 cetostearyl ether potassium citrate propylene glycol water sorbitan monolaurate phenoxyethanol

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43538-952-10 1 CANISTER in 1 CARTON contains a CANISTER 1 100 g in 1 CANISTER This package is contained within the CARTON (43538-952-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201402 02/01/2013

TOVET FOAM (EMOLLIENT FORMULATION) clobetasol propionate kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-953

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43538-953-10 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CANISTER 100 g Part 2 1 TUBE 255 g

Part 1 of 2 TOVET clobetasol propionate aerosol, foam

Product Information Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID cetyl alcohol cyclomethicone glycerin isopropyl myristate polyoxyl 20 cetostearyl ether potassium citrate propylene glycol water sorbitan monolaurate phenoxyethanol

Packaging # Item Code Package Description Multilevel Packaging 1 100 g in 1 CANISTER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201402 02/01/2013

Part 2 of 2 KERADAN cream

Product Information Route of Administration TOPICAL DEA Schedule

Ingredients Ingredient Name Quantity water CETOSTEARYL ALCOHOL medium-chain triglycerides glycerin cetyl alcohol petrolatum polyoxyl 20 cetostearyl ether caprylyl trisiloxane cyclomethicone 5 cyclomethicone 4 stearic acid paraffin polysorbate 20 phenoxyethanol XANTHAN GUM cholesterol allantoin yellow wax methylparaben linoleic acid trolamine edetate disodium squalane .alpha.-tocopherol acetate MICROCRYSTALLINE WAX olive oil aluminum acetate aluminum sulfate calcium acetate sodium lauroyl lactylate LINOLENIC ACID hyaluronate sodium CERAMIDE NP CERAMIDE AP tocopherol

Product Characteristics color WHITE C48325

Packaging # Item Code Package Description Multilevel Packaging 1 255 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 12/01/2011

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201402 02/01/2013

Labeler — Medimetriks Pharmaceuticals, Inc. (019903816)

Establishment
Name	Address	ID/FEI	Operations
Perrigo, Inc.		600093611	MANUFACTURE (43538-952), PACK (43538-952), LABEL (43538-952), ANALYSIS (43538-952)

Revised: 09/2020 Medimetriks Pharmaceuticals, Inc.