Terbinafine hydrochloride cream dosage form is to be in a single-dose or multi-dose vial pack of not more than 10 mL containing (i) 0.6% or 0.8% hydrochloride; (ii) 0.02% (0.03% if the formulation is a cream); and (8) Allergy test kits, including enzyme immunoassay (EIA) and immunoblotting assay. (e) If a drug is approved for the treatment of a disease or condition that is a contraindication to use of the drug in a licensed country or territory, the following information shall be stated in the labeling of that drug: (1) The maximum recommended dosage for duration of use the drug; (2) When the use of drug is contraindicated, a description of the potential benefits and risks associated with its use; and (3) When a person is using the drug, a warning of potential risks and benefits associated with the use of drug. (f) In developing new drug product labeling, the Secretary or FDA may consider the following information, as appropriate: (1) The requirements of subsections (b) and (c) this section; (2) The risks and benefits of treating a disease or condition with the drug; and (3) The need for and feasibility of developing a drug product that addresses the clinical need for drug in a particular population group. (g) When a drug is approved by the FDA for a use in humans, statement that the drug is for treatment of a disease or condition and that it is not currently approved for any other use shall be stated on: (1) The label; and (2) The labeling of all other packaging used with the drug or approved as required by this part. (h) When a drug is approved by the FDA for a use in animals, statement that the drug is not currently approved or presently indicated for use the treatment of a disease or condition in animals shall be stated on the labeling of all packaging used with the drug or approved as required by this part. [78 FR 8529, Feb. 19, 2013] §316.21 Safety information. (a) Each drug product, and ingredient in a drug product, shall be labeled in accordance with the provisions of §§316.22 through 316.26, and this section, which are set forth in descending order of priority by decreasing frequency use. Each product shall be labeled in accordance with the following requirements: (1) The label shall clearly state product name and the names of all ingredients in the product. (2) The label shall include an informative and easily accessible warning statement for each substance: (i) That should be avoided because of its potential for dependence or abuse, including a description of the abuse liability substance(s); (ii) That may be found in the product(s); and (iii) Of which terbinafine cream otc uk use Is viagra over the counter in europe is contraindicated. (3) A canada pharmacy online steroids product shall be labeled in accordance with §316.22 for the type of drug product containing the substance in good manufacturing practice, except that a drug product is not in good manufacturing practice shall be labeled in accordance with §316.22(b), (c), (d), or (e) only. (4) A drug product may be used by a patient only once, but drug product may contain more than one substance. (5) A description of the labeling requirements for each drug product shall be: (i) Provided by the FDA; or (ii) In the case of a drug product approved by the FDA under 15 U.S.C. 360bbb, provided by the Secretary of Health and Human Services. (b) Each component of a drug product shall be labeled in accordance with the provisions of §§316.22 through 316.26 and this section, which are Synthroid buy online uk set forth in descending order of priority by decreasing frequency use. Each component of a drug product shall be labeled in accordance with the following requirements: (1) The label may include any of the following statements: (i) Warning statement(s); (ii) Statement that the drug product is available only by prescription only; and (iii) Statement that the drug product is not available in any form for inhalation or dermal is terbinafine an over the counter drug use other uses. (2) The label may include any of the following statements:.
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