§346.16. Analgesic, anesthetic, and antipruritic active ingredients. — Inbound Citations

21 C.F.R. § 346.16

Statutory Authority

Cited by 2 regulations in release Current.

21 C.F.R. § 346.22(b)

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(b) Any single anorectal ingredient identified in § 346.10, 346.12, 346.16, 346.18, or 346.20 may be combined with up to four protectants in accordance with paragraph (a) of this section.
21 C.F.R. § 346.50

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The labeling of the product contains the following information for anorectal ingredients identified in §§ 346.10, 346.12, 346.14, 346.16, 346.18, and 346.20, and for combinations of anorectal ingredients identified in § 346.22. Unless otherwise specified, the labeling in this subpart is applicable to anorectal drug products for both external and intrarectal use.