...Products, Inc./Hackensack, NJ (M,S) Inadequate directions for safe use by laymen; labeling fails to bear warnings against use in those pathological conditions...children where its use may be dangerous to health. False and misleading claims to provide a sufficient supply of oxygen for one hour; inadequate directions...

...active ingredient, including the quantity, kind, and proportion of any alcohol. . . . (f) Unless its labeling bears (1) adequate directions for use; and...pathological conditions or by children where its use may dangerous to health, or against unsafe dosage or methods or duration of administration or application...

...affect label compliance with the .statutory provisions. (21 CFR 1.105) (f) The labeling must contain (1) adequate directions for use and (2) such adequate...use in those pathological conditions or by children irhere its use may be dangerous to health or against unsafe dosage or methods or duration of administration...

...be misbranded — (a) If its labeling is false or misleading in any particular * * *. (f) Unless its labeling bears (1) adequate directions for use; and...use in those pathological conditions or by children when its use may be dangerous to health, or against unsafe dosages or methods or duration of administration...

...directions for use — 502(0(1); and the articles' labeling lacked adequate warnings against unsafe methods or duration of administration or application, in such manner and form as were necessary to protect users against potentially harmful ultraviolet radiation — 502(0(2). DISPOSITION:...

...drug, in which case the official title used in the Homeopathic Pharmacopeia shall apply. (f) Unless its labeling bears (1) adequate directions for use; and...pathological conditions or by children where its use nay be dangerous to health, or against unsafe dosage or methods or duration of administration or application,...

...misbranded unless it bears "adequate directions for use," and "adequate warnings against use * * * where its use may be dangerous to health, or against...methods or duration of administration or application," and so forth. As a practical matter, these requirements pertain only to OTC drugs since present law...

...the Homoeopathic Pharmacopoeia shall apply. Direction! for use and warning* on label (f) Unless its labeling bears (1) adequate directions for use; and...dosage or methods or duration of administration or apimcaiiviu, in bucii manner aim lurm, as are necessary lor tne protection of users: Provided, That...

...form as may be prescribed by regulations, us provided by sections 701 and 703, against use in such pathological conditions or by children where its use...methods or duration of administration or application. As originally drawn this provision is S. 5 was against use in such pathological conditions or by children...

...impracticable, exemption Khali be established by regulationa promulgated by the Secretary. (f) I il, -• its labeling bears (1) adequate directions for use: and...those pathological conditions or by children where it? use may be dangerous to health, or against unsafe dosage or methods or duration of administration...