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 -- 100 g Canister Carton
(click image for full-size original)

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.

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
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.

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