NDC Code(s) : 0062-0165-01, 0062-0165-02, 0062-0175-12, 0062-0175-13, 0062-0275-23, 0062-0275-01, 0062-0575-44, 0062-0575-46, 0062-0475-42, 0062-0475-45
Packager : Ortho-McNeil Janssen Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Retin-ATretinoin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0062-0165
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin(UNII: 5688UTC01R)
(Tretinoin - UNII:5688UTC01R) 		Tretinoin0.25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Stearic Acid(UNII: 4ELV7Z65AP)
Isopropyl Myristate(UNII: 0RE8K4LNJS)
Polyoxyl 40 Stearate(UNII: 13A4J4NH9I)
Stearyl Alcohol(UNII: 2KR89I4H1Y)
Xanthan Gum(UNII: TTV12P4NEE)
Sorbic Acid(UNII: X045WJ989B)
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0062-0165-011 in 1 CARTON
120 g in 1 TUBE
2NDC:0062-0165-021 in 1 CARTON
245 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019049 10/30/1988
Retin-ATretinoin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0062-0175
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin(UNII: 5688UTC01R)
(Tretinoin - UNII:5688UTC01R) 		Tretinoin0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Stearic Acid(UNII: 4ELV7Z65AP)
Isopropyl Myristate(UNII: 0RE8K4LNJS)
Polyoxyl 40 Stearate(UNII: 13A4J4NH9I)
Stearyl Alcohol(UNII: 2KR89I4H1Y)
Xanthan Gum(UNII: TTV12P4NEE)
Sorbic Acid(UNII: X045WJ989B)
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0062-0175-121 in 1 CARTON
120 g in 1 TUBE
2NDC:0062-0175-131 in 1 CARTON
245 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017522 07/30/1974
Retin-ATretinoin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0062-0275
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin(UNII: 5688UTC01R)
(Tretinoin - UNII:5688UTC01R) 		Tretinoin1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Stearic Acid(UNII: 4ELV7Z65AP)
Isopropyl Myristate(UNII: 0RE8K4LNJS)
Polyoxyl 40 Stearate(UNII: 13A4J4NH9I)
Stearyl Alcohol(UNII: 2KR89I4H1Y)
Xanthan Gum(UNII: TTV12P4NEE)
Sorbic Acid(UNII: X045WJ989B)
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0062-0275-231 in 1 CARTON
120 g in 1 TUBE
2NDC:0062-0275-011 in 1 CARTON
245 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017340 04/30/1973
Retin-ATretinoin GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0062-0575
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin(UNII: 5688UTC01R)
(Tretinoin - UNII:5688UTC01R) 		Tretinoin0.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Hydroxypropyl Cellulose(UNII: RFW2ET671P)
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Alcohol(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0062-0575-441 in 1 CARTON
115 g in 1 TUBE
2NDC:0062-0575-461 in 1 CARTON
245 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017955 07/30/1979
Retin-ATretinoin GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0062-0475
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin(UNII: 5688UTC01R)
(Tretinoin - UNII:5688UTC01R) 		Tretinoin0.25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Hydroxypropyl Cellulose(UNII: RFW2ET671P)
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Alcohol(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0062-0475-421 in 1 CARTON
115 g in 1 TUBE
2NDC:0062-0475-451 in 1 CARTON
245 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017579 07/30/1975

PRINCIPAL DISPLAY PANEL

NDC 0062-0165-01

Retin-A® Cream
(tretinoin) 0.025%

Contains: Tretinoin 0.025%, stearic acid, isopropyl
myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan
gum, sorbic acid, butylated hydroxytoluene,
and purified water

For Topical Use only   NET WT. 20g
Rx only
Dosage: See package insert.
Store below 80° F.
Warning: Keep out of reach of children.

Ortho Dermatologics
Marketed by: Ortho Dermatologics
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 20 g Carton

PRINCIPAL DISPLAY PANEL

NDC 0062-0175-12

Retin-A® Cream
(tretinoin) 0.05%

Contains: Tretinoin 0.05%, stearic acid, isopropyl
myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan
gum, sorbic acid, butylated hydroxytoluene,
and purified water

For Topical Use only   NET WT. 20g
Rx only
Dosage: See package insert.
Store below 80° F.
Warning: Keep out of reach of children.

Ortho Dermatologics
Marketed by: Ortho Dermatologics
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 20 g Carton

PRINCIPAL DISPLAY PANEL

NDC 0062-0275-23

Retin-A® Cream
(tretinoin) 0.1%

Contains: Tretinoin 0.1%, stearic acid, isopropyl
myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan
gum, sorbic acid, butylated hydroxytoluene,
and purified water

For Topical Use only   NET WT. 20g
Rx only
Dosage: See package insert.
Store below 80° F.
Warning: Keep out of reach of children.

Ortho Dermatologics
Marketed by: Ortho Dermatologics
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 20 g Carton

PRINCIPAL DISPLAY PANEL

NDC 0062-0575-44

Retin-A® Gel
(tretinoin) 0.01%

Contains: Tretinoin 0.01%, hydroxypropyl cellulose,
butylated hydroxytoluene, alcohol, (denatured with tert-
butyl alcohol and brucine sulfate) 90% w/w.

For topical Use Only   NET WT. 15g
Rx only
Dosage: See package insert.
Store below 86° F.
Warning: Keep out of reach of children.

Ortho Dermatologics
Marketed by: Ortho Dermatologics
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 15 g Carton

PRINCIPAL DISPLAY PANEL

NDC 0062-0475-42

Retin-A® Gel
(tretinoin) 0.025%

Contains: Tretinoin 0.01%, hydroxypropyl cellulose,
butylated hydroxytoluene, alcohol, (denatured with tert-
butyl alcohol and brucine sulfate) 90% w/w.

For topical Use Only   NET WT. 15g
Rx only
Dosage: See package insert.
Store below 86° F.
Warning: Keep out of reach of children.

Ortho Dermatologics
Marketed by: Ortho Dermatologics
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 15 g Carton