Drug Safety-related Labeling Changes (SrLC)

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Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/19/2018 (SUPPL-19)

Approved Drug Label (PDF)

5 Warnings and Precautions



(additions underlined)


For external use only. Flammable: Keep away from fire or flame

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/diffi ulty breathing

  • shock

  •  facial swelling

  •  hives

  •  rash

If an allergic reaction occurs, stop use and seek medical help right away.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information

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