Aerosoothe Cream
FDA Label NDC 55305-136

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aero Healthcare Us Llc for the product Aerosoothe (NDC 55305-136). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrocortisone 1%

Purpose

Antipruritic (anti-itch)

Uses

  • for temporary relief of itching associated with minor skin irritations and rashes
  • for external genital, feminine, and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only.

Do Not Use

  • for the treatment of diaper rash, consult a doctor
  • with any other hydrocortisone product unless you have consulted a doctor
  • if you have a vaginal discharge, consult a doctor

When Using This Product

  • avoid contact with the eyes
  • do not put this product into rectum by using fingers, mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
  • rectal bleeding occurs

Keep Out Of The Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • For itching or skin irritation, inflammation, and rashes: Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: do not use unless directed by a doctor
  • For external anal and genital itching, Adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily

Inactive Ingredients

Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl stearate, Mineral oil, Petrolatum, Phenoxyethanol, Water.

Questions?

Call 1-845-618-7037

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