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

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

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

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

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

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