FDA OTC active ingredients.pdfVIP

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FDA OTC active ingredients

OTC Active Ingredients April 7, 2010 UNII Code Active Ingredient Monograph Sub-category Panel Pending Final FR Citation 18B8O9DQA2 alcloxa acne II II 310.545(a)(1) alkyl isoquinolinium bromide acne II II 310.545(a)(1) aluminum chlorohydrex acne II II 310.545(a)(1) 5QB0T2IUN0 aluminum hydroxide acne II II 310.545(a)(1) U3RSY48JW5 benzocaine acne II II 310.545(a)(1) 8SKN0B0MIM benzoic acid acne II II 310.545(a)(1) W9WZN9A0GM benzoyl peroxide acne I I- IIIS 333.310(a) 75 FR 9767 R57ZHV85D4 boric acid acne II II 310.545(a)(1) calcium polysuldfide acne II II 310.545(a)(1) 210100728E calcium thiosulfate acne II II 310.545(a)(1) 5TJD82A1ET camphor acne II II 310.545(a)(1) BPF36H1G6S chlorhydroxyquinoline (cloxyquin) acne II II 310.545(a)(1) LJ25TI0CVT chloroxylenol acne II II 310.545(a)(1) BPF36H1G6S cloxyquin (chlorhydroxyquinoline) acne 310.545(a)(1) R533ES02EC coal tar acne II II 310.545(a)(1) Z3D4AJ1R48 dibenzothiophene acne II II 310.545(a)(1) 2DI9HA706A estrone acne II II 310.545(a)(1) 6M2P64V0NC magnesium aluminum silicate acne 310.545(a)(1) DE08037SAB magnesium sulfate acne II II 310.545(a)(1) 339NCG44TV phenol acne II II 310.545(a)(1) 4NC0T56V35 phenolate sodium acne II II 310.545(a)(1) 28A37T47QO phenyl salicylate acne II II 310.545(a)(1) 85H0HZU99M povidone-iodine acne III III 310.545(a)(1) R35D29L3ZA pyrilamine maleate acne II II 310.545(a)(1) YUL4LO94HK resorcinol (as single ingredient only) acne III II 310.545(a)(1) YUL4LO94HK resorcinol (when combined with sulfur) acne 333.310(b) YUL4LO94HK resorcinol monoacetate (as single ingredient only) acne III II 310.545(a)(1) YUL4LO94HK resorcinol monoacetate (when combined with sulfur) acne 333.310(c) O414PZ4LPZ salicylic acid acne III I 333.310(d) O414PZ4LPZ salicylic acid (over 2 up to 5%) acne III III 310.545(a)(1) 91MBZ8H3QO sodium borate acne II II 310.545(a)(1) HX1032V43M sodium thiosulfate acne II II 310.545(a)(1) 70FD1KFU70 sulfur acne I I 333.310(e) 70FD1KFU70 sulfur (when

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