Iasobetic Allantoin Skin Protectant
FDA Label NDC 72904-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Iasobetic Wound Care Corp. for the product Iasobetic Allantoin Skin Protectant (NDC 72904-001). 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 active ingredient, purpose, use, warnings, when using this product, 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

Allantoin 2%

Purpose

Skin Protectant

Use

  • temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • helps prevent and temporarily protects chafed, chapped or cracked skin

Warnings

For external use only

When Using This Product

  • do not get into eyes.

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

apply as needed

Other Information

Store at room temperature 15-27° C (59-80° F)

Inactive Ingredients

Aloe vera leaf juice, shea butter, turmeric, coconut oil, carbomer, cetyl alcohol, dimethicone, diatomite, glucosamine, glycol stearate SE, EDTA disodium, ethylhexylglycerin, glycerin, isopropyl myristate, laureth-8, lecithin, gotu kola, stearic acid, plantain leaf extract powder, phenoxyethanol, hydrogenated polydecene, purified water, pullulan, sodium acrylate/sodium acryloyldimethyl taurate copolymer, sclerotium gum, triethanolamine, xanthan gum.

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