21 CFR Part 201 — Labeling
Subpart A — General Labeling Provisions
Subpart B — Labeling Requirements for Prescription Drugs and/or Insulin
Subpart C — Labeling Requirements for Over-the-Counter Drugs
Subpart D — Exemptions From Adequate Directions for Use
Subpart E — Other Exemptions
Subpart F — Labeling Claims for Drugs in Drug Efficacy Study
Subpart G — Specific Labeling Requirements for Specific Drug Products
- § 201.300— Notice to manufacturers, packers, and distributors of glandular preparations.
- § 201.301— Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
- § 201.302— Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
- § 201.303— Labeling of drug preparations containing significant proportions of wintergreen oil.
- § 201.304— Tannic acid and barium enema preparations.
- § 201.305— Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
- § 201.306— Potassium salt preparations intended for oral ingestion by man.
- § 201.307— Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
- § 201.308— Ipecac syrup; warnings and directions for use for over-the-counter sale.
- § 201.309— Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
- § 201.310— Phenindione; labeling of drug preparations intended for use by man.
- § 201.312— Magnesium sulfate heptahydrate; label declaration on drug products.
- § 201.313— Estradiol labeling.
- § 201.314— Labeling of drug preparations containing salicylates.
- § 201.315— Over-the-counter drugs for minor sore throats; suggested warning.
- § 201.316— Drugs with thyroid hormone activity for human use; required warning.
- § 201.317— Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
- § 201.319— Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions.
- § 201.320— Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
- § 201.323— Aluminum in large and small volume parenterals used in total parenteral nutrition.
- § 201.325— Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
- § 201.326— Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
- § 201.327— Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
- § 201.328— Labeling of medical gas containers.