Manuka Honey Extra Strength Gel
FDA Label NDC 81995-050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Honey Llc for the product Manuka Honey Extra Strength (NDC 81995-050). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, 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

Drug Facts

Active Ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only

Do Not Use

  • In the eyes
  • On deep or puncture wounds
  • Animal bites
  • Serious burns

Stop Use And Ask A Doctor If

  • Conditions worsen
  • 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 a Poison Control Center right away.

Directions

Apply as needed.

Inactive Ingredients

Helianthus Annuus Extract, Lecithin, Mãnuka Honey, Oryza Sativa Bran Extract, Propanediol, Potassium Sorbate, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Sodium Benzoate, Tetrasodium Glutamate Diacetate, Tocopherol, Water (Aqua).

Questions?

1-615-488-8168

Package Labeling:

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