21 C.F.R. § 347.20 Permitted combinations of active ingredients.
Title 21 - Food and Drugs
(a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in §347.10(a), (d), (e), (i), (k), (l), (m), and (r) may be combined provided the combination is labeled according to §347.50(b)(1) and provided each ingredient in the combination is within the concentration specified in §347.10. (2) Any two or more of the ingredients identified in §347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) may be combined provided the combination is labeled according to §347.50(b)(2) and provided each ingredient in the combination is within the concentration specified in §347.10. (3) Any two or more of the ingredients identified in §347.10(b), (c), (j), (s), (t), and (u) may be combined provided the combination is labeled according to §347.50(b)(3) and provided each ingredient in the combination is within the concentration specified in §347.10. (4) The ingredients identified in §347.10(f) and (l) may be combined provided the combination is labeled according to §347.50(b)(7) and provided each ingredient in the combination is within the concentration specified in §347.10. (b) Combinations of skin protectant and external analgesic active ingredients. Any one (two when required to be in combination) or more of the active ingredients identified in §347.10(a), (d), (e), (i), (k), (l), (m), and (r) may be combined with any of the following generally recognized as safe and effective external analgesic active ingredients: Single amine and “caine”-type local anesthetics, alcohols and ketones, antihistamines, or any permitted combination of these ingredients, but not with hydrocortisone, provided the product is labeled according to §347.60(b)(l). (c) Combinations of skin protectant and first aid antiseptic active ingredients. Any one (two when required to be in combination) or more of the active ingredients identified in §347.10(a), (d), (e), (i), (k), (l), (m), and (r) may be combined with any generally recognized as safe and effective single first aid antiseptic active ingredient, or any permitted combination of these ingredients, provided the product is labeled according to §347.60(b)(2). (d) Combinations of skin protectant and sunscreen active ingredients. Any one (two when required to be in combination) or more of the skin protectant active ingredients identified in §347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) may be combined with any generally recognized as safe and effective single sunscreen active ingredient, or any permitted combination of these ingredients, provided the product meets the conditions in §352.20(b) of this chapter and is labeled according to §§347.60(b)(3) and 352.60(b) of this chapter. Effective Date Note: At 68 FR 33377, June 4, 2003, in §347.20 paragraph (d) was stayed until further notice, effective June 4, 2004.
Title 21: Food and Drugs
PART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 347.20 Permitted combinations of active ingredients.
