Prescription Drug Information: Retin-A MICRO (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 50g Bottle Pump Carton

NDC 0062-0190-11

RETIN-A MICRO®
(tretinoin gel) microsphere, 0.1%

PUMP

For Topical Use Only
Rx Only

ORTHODERMATOLOGICS™

NET WT. 50g

Principal Display Panel -- 50g Bottle Pump Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50g Bottle Pump Carton

NDC 0062-0204-11

RETIN-A MICRO®
(tretinoin gel) microsphere, 0.04%

PUMP

For Topical Use Only
Rx Only

ORTHODERMATOLOGICS™

NET WT. 50g

Principal Display Panel -- 50g Bottle Pump Carton
(click image for full-size original)
RETIN-A MICRO tretinoin gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0062-0190
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
Benzyl Alcohol
Butylated Hydroxytoluene
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)
Edetate Disodium
Glycerin
Propylene Glycol
Water
Sorbic Acid
Trolamine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0062-0190-01 1 TUBE in 1 CARTON contains a TUBE
1 2 g in 1 TUBE This package is contained within the CARTON (0062-0190-01)
2 NDC:0062-0190-02 1 TUBE in 1 CARTON contains a TUBE
2 20 g in 1 TUBE This package is contained within the CARTON (0062-0190-02)
3 NDC:0062-0190-03 1 TUBE in 1 CARTON contains a TUBE
3 45 g in 1 TUBE This package is contained within the CARTON (0062-0190-03)
4 NDC:0062-0190-11 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
4 50 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0062-0190-11)
5 NDC:0062-0190-15 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
5 30 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0062-0190-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020475 05/01/2011
RETIN-A MICRO tretinoin gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0062-0204
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tretinoin (Tretinoin) Tretinoin 0.4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol
Butylated Hydroxytoluene
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)
Edetate Disodium
Glycerin
Propylene Glycol
Water
Sorbic Acid
Trolamine
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0062-0204-01 1 TUBE in 1 CARTON contains a TUBE
1 2 g in 1 TUBE This package is contained within the CARTON (0062-0204-01)
2 NDC:0062-0204-02 1 TUBE in 1 CARTON contains a TUBE
2 20 g in 1 TUBE This package is contained within the CARTON (0062-0204-02)
3 NDC:0062-0204-03 1 TUBE in 1 CARTON contains a TUBE
3 45 g in 1 TUBE This package is contained within the CARTON (0062-0204-03)
4 NDC:0062-0204-11 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
4 50 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0062-0204-11)
5 NDC:0062-0204-15 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
5 30 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0062-0204-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020475 05/01/2011
Labeler — Ortho-McNeil Pharmaceuticals (010779978)
Establishment
Name Address ID/FEI Operations
Janssen Ortho LLC 805887986 MANUFACTURE (0062-0190), MANUFACTURE (0062-0204)

Revised: 10/2016 Ortho-McNeil Pharmaceuticals

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