FDA.reportPublic FDA data

Manuka Honey Ointment Extra Strength

Manufacturer
First Honey LLC
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:24

Label at a glance#

ProductManuka Honey Extra Strength
Active ingredientALLANTOIN
Label structure7 sections

Indications and uses

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

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Conditions worsen
  • Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-615-488-8168

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81995-050-01Manuka Honey Extra Strength1 in 1 CARTONGEL13
81995-050-01Manuka Honey Extra Strength21 g in 1 TUBEGEL213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81995-050MANUKA HONEY EXTRA STRENGTH (ALLANTOIN) GEL [FIRST HONEY LLC]3Current NDC, 2 package rows20250206_b742585d-9a0c-489b-b268-590583cfabd1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81995-05081995-050-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ROSEMARYIJ67X351P9IACT
SODIUM BENZOATEOJ245FE5EUIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
ALLANTOIN344S277G0ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Manuka Honey Extra StrengthALLANTOINFirst Honey LLCb742585d-9a0c-489b-b268-590583cfabd12025-02-04WarningsExact identifier
ndc (package): 81995-050-01
ndc (product): 81995-050
ndc11 (package): 81995005001
spl id: 2d5e1f54-b018-fce5-e063-6394a90a76d7
spl set id: b742585d-9a0c-489b-b268-590583cfabd1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.