Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment
other · Food and Drug Administration · Rule · Published 2008-02-01 · Effective 2008-03-03 · 73 FR 6014
Document
Document number
E8-1818
Federal Register citation
73 FR 6014
CFR reference
21 CFR 347
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-02-01
Effective date
2008-03-03
HHS docket
Docket Nos. 1978N-0021 and 1978N-0021P
Abstract
The Food and Drug Administration (FDA) is amending the regulation that establishes conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective (GRASE) and not misbranded. This amendment revises labeling requirements for OTC skin protectant drug products formulated and marketed as lip protectants.