Biocorneum Hc Advanced Scar Supervision Anti-itch
FDA Label NDC 43474-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Enaltus Inc for the product Biocorneum Hc Advanced Scar Supervision Anti-itch (NDC 43474-000). 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, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient


Hydrocortisone acetate 1%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, soaps, detergents and cosmetics.

Warnings

For external use only

Do Not Use

  • in or near the eyes 
  • for the treatment of diaper rash: ask a doctor

Stop Use And Ask A Doctor If

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

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

Directions

  • ensure that affected area is clean and dry 
  • apply evenly in a very thin layer to affected area not more than 3 to 4 times daily 
  • children under 2 years of age : consult a doctor

Other Information

  • store below 25 degree (77 degree F)

Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethyl Isosorbide, Pentylene Glycol, Propylene Glycol, Silicon Dioxide

Manufactured In The Usa For: Enaltus Suwanee, Ga 30024 Usa 2012 Enaltus


Biocorneum Hc Advanced Scar Supervision Anti-Itch Gel 5G (43474-000-05)


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