Burn Relief Cream

Manufacturer
HUMN Pharmaceuticals Inc | Delta Pharma Inc | Delta Pharma Inc.
Effective date
2018-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:37

Label at a glance#

ProductBurn Relief
Active ingredientMENTHOL, LIDOCAINE HYDROCHLORIDE ANHYDROUS, ALLANTOIN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Allantoin 1.5% (w/w)

Lidocaine Hydrochloride 4.0% (w/w)

Menthol 1.0% (w/w)

OTC - PURPOSE SECTION

Purpose

Skin protectant

Anesthetic

Analgesic, anesthetic, and antipruritic

INDICATIONS & USAGE SECTION

Uses

Temporary relief of pain associated with:

▪ minor burns ▪ minor skin irritations

Temporary protection of minor skin irritations

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

in large quantities, particularly:

• over raw surfaces • over blistered areas

OTC - ASK DOCTOR SECTION

Ask a doctor before use

if child is under 2 years of age, and use only as directed

OTC - WHEN USING SECTION

When using this product

• avoid contact with eyes; if this happens, rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor

• condition worsens • if symptoms persist for more than 7 days

• clear up and occur again within a few days • you experience: pain, swelling, or blistering

• you experience: weakness, confusion, headache, difficulty breathing, or any unusual symptoms

• you experience: pale, grey or blue-coloured skin, lips, or nail beds

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

INFORMATION FOR PATIENTS SECTION

Other information

• do not use if seal is broken

• store at 60-85° F

INACTIVE INGREDIENT SECTION

Inactive ingredients

Acrylates/Acrylamide Copolymer, Alpha-Lipoic Acid, Beeswax, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteraryl Alcohol, Ceteth-20, Ceteth-10 Phosphate, Denatured Alcohol, Dicetyl Phosphate, Dimethicone, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Laureth-7, Lecithin, Mineral Oil, PEG-6 Stearate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 85, Purified Water, Steareth-2, Steareth-20, Steareth-21.

OTC - QUESTIONS SECTION

Questions?

1-866-335-3596 Monday to Friday 8 am to 6 pm EST .

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn Relief Label.jpg

Burn Relief LabelBurn Relief Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2045344allantoin 1.5 % / lidocaine HCl 4 % / menthol 1 % Topical CreamPSN1
2045344allantoin 15 MG/ML / lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD1
2045344allantoin 1.5 % / lidocaine HCl 4 % / menthol 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72042-003-032024-01-30C16284748780-11030e365-6e07-111a-e063-dadaa90a10e2Burn Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72042-003-03Burn Relief28300 mg in 1 TUBECREAM283001
72042-003-03Burn Relief1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72042-003BURN RELIEF (ALLANTOIN, LIDOCAINE, MENTHOL) CREAM [HUMN PHARMACEUTICALS INC]1Legacy NDC, 2 package rows20180520_6c948545-cd5a-5371-e053-2a91aa0a7cc1.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72042-00372042-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
6c948545-cd5c-5371-e053-2a91aa0a7cc16c948545-cd5a-5371-e053-2a91aa0a7cc12018-05-19WarningsExact identifier
spl id: 6c948545-cd5c-5371-e053-2a91aa0a7cc1
spl set id: 6c948545-cd5a-5371-e053-2a91aa0a7cc1

Reported adverse events (FAERS/openFDA)#

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