FDA.reportPublic FDA data

First honey Burn Salve

Manufacturer
First Honey, LLC
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:26

Label at a glance#

ProductFirst honey Burn Salve
Active ingredientALLANTOIN
Label structure8 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

When using product

OTC - WHEN USING SECTION

  • do not get into eyes

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

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture
  • wounds
  • Animal bites
  • Serious burns

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

Aloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Argania Spinosa Kernel Oil, Benzyl Alcohol, Caprylic/Capric Triglyceride, Cucumis Sativus Fruit Extract, Ethylhexylglycerin, Helianthus Annuus Extract, Lavandula Angustifolia Oil, Lecithin, Manuka Honey, Mixed Tocopherols, Oryza Sativa Bran Extract, Propanediol, Rosa Canina Seed Oil, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Soya Bean Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Water (Aqua).

Questions or comments?

OTC - QUESTIONS SECTION

1-615-212-8585

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

Package Labeling: 81995-056-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5mL label5mL label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
241509allantoin 0.5 % Topical CreamPSN4
241509allantoin 5 MG/ML Topical CreamSCD4
241509allantoin 0.5 % Topical CreamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81995-056-012025-02-05C16284748780-12cef2736-9130-d83d-e063-dadaa90ab31fFirst honey Burn Salve
81995-056-022025-02-05C16284748780-12cef2736-9130-d83d-e063-dadaa90ab31fFirst honey Burn Salve
81995-056-012025-01-30C16284748780-12cef2736-9130-d83d-e063-dadaa90ab31fFirst honey Burn Salve
81995-056-022025-01-30C16284748780-12cef2736-9130-d83d-e063-dadaa90ab31fFirst honey Burn Salve

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81995-056-01First honey Burn Salve1 in 1 CARTONCREAM14
81995-056-01First honey Burn Salve100 mL in 1 TUBECREAM1004
81995-056-02First honey Burn Salve1 in 1 CARTONCREAM14
81995-056-02First honey Burn Salve5 mL in 1 POUCHCREAM54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81995-056FIRST HONEY BURN SALVE (ALLANTOIN) CREAM [FIRST HONEY, LLC]4Current NDC, 4 package rows20250206_f40a9a34-1827-7171-e053-2a95a90acf31.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81995-05681995-056-01, 81995-056-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
ARGAN OIL4V59G5UW9XIACT
BENZYL ALCOHOLLKG8494WBHIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LAVENDER OILZBP1YXW0H8IACT
HONEYY9H1V576FHIACT
TOCOPHEROLR0ZB2556P8IACT
PROPANEDIOL5965N8W85TIACT
ROSA CANINA SEED OILMHT97MG5P8IACT
ROSEMARYIJ67X351P9IACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
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
First honey Burn SalveALLANTOINFirst Honey, LLCf40a9a34-1827-7171-e053-2a95a90acf312025-02-04WarningsExact identifier
ndc (package): 81995-056-02
ndc (package): 81995-056-01
ndc (product): 81995-056
ndc11 (package): 81995005601
ndc11 (package): 81995005602
spl id: 2d5e186d-35d6-81b9-e063-6294a90a9daa
spl set id: f40a9a34-1827-7171-e053-2a95a90acf31

Reported adverse events (FAERS/openFDA)#

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