Eczenil
FDA Label NDC 76066-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healingsmith Institute Inc. for the product Eczenil (NDC 76066-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Colloidal Oatmeal 2%

Otc - Purpose

Skin Protectant

Indications & Usage

Uses
temporarily protects and helps relieve minor skin irritation and itching due to:

  • eczema
  • rashes
  • insect bites
  • poison ivy, oak or sumac

Warnings

Warnings
For external use only.

Otc - Do Not Use

Do not use if you are allergic to sesame oil.

Otc - When Using

When using this product

  • do not get into eyes
  • if you currently use steroids or have used steroids in the recent past, it may take 1 to 3 months to see results

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • apply twice a day or as needed

Storage And Handling

Other Information

  • store in a cool and dry place

Inactive Ingredient

Inactive Ingredients
BHT, Cetyl Alcohol, Coccinia Indica fruit extract, Fragrance, Holarrhena Atidysenterica leaf extract, Melia Azadirachta leaf extract, Propylene Glycol, Sesamum Indicum (Sesame) seed oil, Sodium Lauryl Sulfate, Sodium Methylparaben, Sodium Propylbaraben, Stearic Acid, White soft paraffin

Package Label.Principal Display Panel

Eczenil Carton (Eczenil)

Eczenil Carton (Eczenil)

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