NDC Code(s) : 0245-0169-01, 0245-0169-20, 0245-0168-06, 0245-0168-12, 0245-0168-20
Packager : Upsher-Smith Laboratories, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cleniasulfacetamide sodium and sulfur CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0169
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sulfacetamide sodium(UNII: 4NRT660KJQ)
(sulfacetamide - UNII:4965G3J0F5) 		sulfacetamide100 mg in 1 g
sulfur(UNII: 70FD1KFU70)
(sulfur - UNII:70FD1KFU70) 		sulfur50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
allantoin(UNII: 344S277G0Z)
edetate disodium(UNII: 7FLD91C86K)
Glyceryl Monostearate(UNII: 230OU9XXE4)
isopropyl myristate(UNII: 0RE8K4LNJS)
methylparaben(UNII: A2I8C7HI9T)
polyoxyl 8 stearate(UNII: 2P9L47VI5E)
propylene glycol(UNII: 6DC9Q167V3)
propylparaben(UNII: Z8IX2SC1OH)
water(UNII: 059QF0KO0R)
sodium thiosulfate(UNII: HX1032V43M)
stearic acid(UNII: 4ELV7Z65AP)
xanthan gum(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0245-0169-011 in 1 CARTON
128 g in 1 TUBE
2NDC:0245-0169-201 in 1 CARTON
23 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2009
Cleniasulfacetamide sodium and sulfur CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0168
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sulfacetamide sodium(UNII: 4NRT660KJQ)
(sulfacetamide - UNII:4965G3J0F5) 		sulfacetamide100 mg in 1 g
sulfur(UNII: 70FD1KFU70)
(sulfur - UNII:70FD1KFU70) 		sulfur50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
butylated hydroxytoluene(UNII: 1P9D0Z171K)
edetate disodium(UNII: 7FLD91C86K)
Glyceryl Monostearate(UNII: 230OU9XXE4)
polyoxyl 100 stearate(UNII: YD01N1999R)
magnesium aluminum silicate(UNII: 6M3P64V0NC)
methylparaben(UNII: A2I8C7HI9T)
propylene glycol(UNII: 6DC9Q167V3)
propylparaben(UNII: Z8IX2SC1OH)
water(UNII: 059QF0KO0R)
silicon dioxide(UNII: ETJ7Z6XBU4)
sodium thiosulfate(UNII: HX1032V43M)
stearic acid(UNII: 4ELV7Z65AP)
titanium dioxide(UNII: 15FIX9V2JP)
xanthan gum(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0245-0168-061 in 1 CARTON
1170 g in 1 BOTTLE
2NDC:0245-0168-121 in 1 CARTON
2340 g in 1 BOTTLE
3NDC:0245-0168-2020 in 1 CARTON
35 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2009

PRINCIPAL DISPLAY PANEL

NDC 0245-0169-01

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Emollient Cream

1 oz (28 g)

UPSHER-SMITH

Principal Display Panel - 28 g tube label

PRINCIPAL DISPLAY PANEL

NDC 0245-0169-01

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Emollient Cream

1 oz (28 g)

UPSHER-SMITH

Principal Display Panel - 28 g tube carton

PRINCIPAL DISPLAY PANEL

NDC 0245-0169-20

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Emollient Cream

3 g (0.1 oz)

UPSHER-SMITH

Principal Display Panel - 3 g sample tube label

PRINCIPAL DISPLAY PANEL

NDC 0245-0169-20

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Emollient Cream

20 tubes of 3 g (0.1 oz) each
PROFESSIONAL SAMPLES: Not for Sale

UPSHER-SMITH

Principal Display Panel - 3 g sample tube carton

PRINCIPAL DISPLAY PANEL

NDC 0245-0168-06

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Foaming Wash

6 oz (170 g)

UPSHER-SMITH

2003765
R0505

Principal Display Panel - 170 g bottle labelPrincipal Display Panel - 170 g bottle label

PRINCIPAL DISPLAY PANEL

NDC 0245-0168-06

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Foaming Wash

6 oz (170 g)

UPSHER-SMITH

Principal Display Panel - 170 g bottle carton

PRINCIPAL DISPLAY PANEL

NDC 0245-0168-12

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Foaming Wash

12 oz (340 g)

UPSHER-SMITH

2003771
R0505

Principal Display Panel - 340 g bottle labelPrincipal Display Panel - 340 g bottle label

PRINCIPAL DISPLAY PANEL

NDC 0245-0168-12

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Foaming Wash

12 oz (340 g)

UPSHER-SMITH

Principal Display Panel - 340 g bottle carton

PRINCIPAL DISPLAY PANEL

NDC 0245-0168-20

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Foaming Wash

5 g (0.2 oz)

UPSHER-SMITH

Principal Display Panel - 5 g sample bottle label

PRINCIPAL DISPLAY PANEL

NDC 0245-0168-20

Rx only

CLENIA®
(sodium sulfacetamide 10% and sulfur 5%)

Foaming Wash

20 packets of 5 g (0.2 oz) each
PROFESSIONAL SAMPLES: Not for Sale

UPSHER-SMITH

Principal Display Panel - 5 g sample bottle carton