Retin-A (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 0.025% 45 g Cream Carton

NDC 0187-5160-45

Retin-A® Cream
(tretinoin) 0.025%

Each gram 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
Rx only
Usual Dosage: See package insert.
Store below 80°F. WARNING: Keep out of reach of children.

Net Wt. 45 g

0.025-45g-cream-carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.05% 45 g Cream Carton

NDC 0187-5162-45

Retin-A® Cream
(tretinoin) 0.05%

Each gram 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
Rx only
Usual Dosage: See package insert.
Store below 80°F. WARNING: Keep out of reach of children.

Net Wt. 45 g

0.05-45g-cream-carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.1% 45 g Cream Carton

NDC 0187-5164-45

Retin-A® Cream
(tretinoin) 0.1%

Each gram 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
Rx only
Usual Dosage: See package insert.
Store below 80°F. WARNING: Keep out of reach of children.

Net Wt. 45 g

0.1-45g-cream-carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.01% 45 g Gel Carton

NDC 0187-5172-45

Retin-A® Gel
(tretinoin) 0.01%

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

For Topical Use Only
Rx only
Usual Dosage: See package insert.
Store below 86°F. WARNING: Keep out of reach of children.

Net Wt. 45 g

0.01-45g-gel-carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.025% 45 g Gel Carton

NDC 0187-5170-45

Retin-A® Gel
(tretinoin) 0.025%

Each gram contains: Tretinoin 0.025%, butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with tert- butyl alcohol and brucine sulfate) 90% w/w.

For Topical Use Only
Rx only
Usual Dosage: See package insert.
Store below 86°F. WARNING: Keep out of reach of children.

Net Wt. 45 g

0.025-45g-gel-carton
(click image for full-size original)
RETIN-A tretinoin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5160
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin (Tretinoin) Tretinoin 0.25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Stearic Acid
Isopropyl Myristate
Polyoxyl 40 Stearate
Stearyl Alcohol
Xanthan Gum
Sorbic Acid
Butylated Hydroxytoluene
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5160-20 1 TUBE in 1 CARTON contains a TUBE
1 20 g in 1 TUBE This package is contained within the CARTON (0187-5160-20)
2 NDC:0187-5160-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0187-5160-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019049 10/30/1988
RETIN-A tretinoin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5162
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin (Tretinoin) Tretinoin 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Stearic Acid
Isopropyl Myristate
Polyoxyl 40 Stearate
Stearyl Alcohol
Xanthan Gum
Sorbic Acid
Butylated Hydroxytoluene
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5162-20 1 TUBE in 1 CARTON contains a TUBE
1 20 g in 1 TUBE This package is contained within the CARTON (0187-5162-20)
2 NDC:0187-5162-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0187-5162-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017522 07/30/1974
RETIN-A tretinoin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5164
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin (Tretinoin) Tretinoin 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Stearic Acid
Isopropyl Myristate
Polyoxyl 40 Stearate
Stearyl Alcohol
Xanthan Gum
Sorbic Acid
Butylated Hydroxytoluene
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5164-20 1 TUBE in 1 CARTON contains a TUBE
1 20 g in 1 TUBE This package is contained within the CARTON (0187-5164-20)
2 NDC:0187-5164-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0187-5164-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017340 04/30/1973
RETIN-A tretinoin gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5172
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin (Tretinoin) Tretinoin 0.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene
Alcohol
TERT-BUTYL ALCOHOL
BRUCINE SULFATE HEPTAHYDRATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5172-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0187-5172-15)
2 NDC:0187-5172-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0187-5172-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017955 07/30/1979
RETIN-A tretinoin gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5170
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin (Tretinoin) Tretinoin 0.25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene
Alcohol
TERT-BUTYL ALCOHOL
BRUCINE SULFATE HEPTAHYDRATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5170-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0187-5170-15)
2 NDC:0187-5170-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0187-5170-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017579 07/30/1975
Labeler — Bausch Health US, LLC (831922468)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies Inc. 245141858 MANUFACTURE (0187-5160), MANUFACTURE (0187-5162), MANUFACTURE (0187-5164), MANUFACTURE (0187-5172), MANUFACTURE (0187-5170)

Revised: 09/2019 Bausch Health US, LLC

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