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OTC DANDRUFF/SUNSCREEN CATEGORY/INGREDIENT COMBOS SHOULD BE "EXPRESSLY ALLOWED"

Executive Summary

OTC DANDRUFF/SUNSCREEN CATEGORY/INGREDIENT COMBOS SHOULD BE "EXPRESSLY ALLOWED" in the final monograph on Dandruff, Seborrheic Dermatitis and Psoriasis Drug Products, the Proprietary Association (P-A) urged FDA in Oct. 29. Noting that coal tar products, under the TFM, must contain a warning statment against exposure to the sun for 24 hours after application, P-A maintained that "FDA has recognized a role for rational, concurrent therapy which would be provided by Category I combination of a sunscreen and an antidandruff, seborrheic dermatitis, or psoriasis ingredient by requiring the . . . warning." The dandruff/sunscreen combination is one of eight specific combinations of Category I ingredients P-A is requesting FDA to allow under the final monograph. "Combinations of appropriate Category I skin protectants, external analgesic ingredients (e.g., salicylic acid and/or coal tar) are rational and of value to those consumers with the concurrent symptoms of itching scaling and dryness of psoriasis," P-A maintained. "Therefore," the association stated, "the following combinations of Category I ingredients . . . should be allowed": "Any external analgesic ingredient . . . and any antidandruff ingredient." "Any external analgesic . . . and any psoriasis-controlling ingredient." "A keratolytic ingredient . . . and any psoriasis-controlling ingredient." "A keratolytic ingredient . . . and any external analgesic ingredient . . . plus any psoriasis-controlling or antidandruff ingredient." "Any sun protectant ingredient and a keratolytic ingredient plus any ingredient controlling dandruff, psoriasis or seborrheic dermatitis." "Any skin protectant ingredient and an external analgesic ingredient . . . plus any ingredient controlling psoriasis or seborrheic dermatitis." "Any skin protectant ingredient and any sun protectant ingredient plus any psoriasis-controlling ingredient." "Any skin protectant ingredient and any psoriasis-controlling ingredient." Commenting on the warning statements proposed in the TFM, which was published in the July 30 Federal Register ("The Pink Sheet" Aug. 4, p. 3), P-A stated that "several of these warnings are redundant, inapplicable or contradictory in nature and would serve more to confuse consumers then to provide reasonable and supportable aids to safe consumer use of these products." For example, the association commented that "the admonition to avoid undue exposure to sunlight following application of coal tar products . . . is inappropriate for wash-off products for the scalp (i.e., dandruff, seborrheic dermatitis, or psoriasis of the scalp), or to hair grooming products which are used by persons with enough hair to protect them from the sun."

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