Novartis Consumer Health

FDA Drug Class III Terminated

4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles

March 7, 2013 Novartis Consumer Health 538,092/.5-fl. oz. bottles, 1,186,740/1-oz. bottles, and 138,528/1.25-fl. oz bottles units

FDA Drug Class III Terminated

4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

March 7, 2013 Novartis Consumer Health 227,124 bottles units

FDA Drug Class III Terminated

Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.

March 7, 2013 Novartis Consumer Health 240,120/2-oz. tubes and 429,144/4-oz. tubes units

FDA Drug Class III Terminated

Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany,

March 7, 2013 Novartis Consumer Health 91,872/1-oz. tubes and 94,464/2-oz. tubes units

FDA Drug Class III Terminated

4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis

March 7, 2013 Novartis Consumer Health 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles units

FDA Drug Class III Terminated

Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 3006763823

February 19, 2013 Novartis Consumer Health 99,660 tubes units

FDA Drug Class III Terminated

Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Ve

February 19, 2013 Novartis Consumer Health 219,600 tubes units

FDA Drug Class III Terminated

Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (C

February 19, 2013 Novartis Consumer Health 41,400 Boxes units

FDA Drug Class III Terminated

Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g

February 19, 2013 Novartis Consumer Health a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes units

FDA Drug Class III Terminated

Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067

February 19, 2013 Novartis Consumer Health 818,064 (12-gm) tubes and 836,376 (30-gm) tubes units