FDA.reportPublic FDA data

Burn Relief Gel

Manufacturer
Cross Brands Contract Filling
Effective date
2021-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:19

Label at a glance#

ProductBurn Relief Gel
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporary relief of pain and itching. Helps to relieve and soothe pain from sunburn, minor burns, skin irritations, scrapes, insect bites.

Dosage and administration

Adults and children 2 years or older: apply generously to the burned area. Repeat application as often as necessary (no more than four times daily) to further extinguish pain. Children under 2 years of age: do not use, ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsActive ingredients

Lidocaine Hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

PurposePurpose

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

UsesUses

Temporary relief of pain and itching. Helps to relieve and soothe pain from sunburn, minor burns, skin irritations, scrapes, insect bites.

Warnings

WARNINGS SECTION

WarningsWarnings

For external use only

Other Warnings

WARNINGS AND PRECAUTIONS SECTION

other warningother warning

Avoid Contact with eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop useStop use

Pregnancy/breast-feeding warning

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, as a health care professional before use.

Do not use

OTC - DO NOT USE SECTION

in large quantity, particularly over raw surfaces or areas with blisters. do not usedo not use

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. Keep out of reach of childrenKeep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years or older: apply generously to the burned area. Repeat application as often as necessary (no more than four times daily) to further extinguish pain. Children under 2 years of age: do not use, ask a doctor DirectionsDirections

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C1030 alkyl acrylate crosspolymer, alcohol denatured, algae extract, aloe barbadensis leaf juice, butylene glycol, ehtylhexylglycerin, FD&C Blue No. 1, fragrance, glycerin, menthyl lactate, PEG-40 hydrogenated castor oil, phenoxyethanol, polysorbate 20, PPG-26-butheth-26, simmondsia chinensis (jojoba) extract, triethanolamine, water. Inactive ingredientsInactive ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 855-sea-n-ski (855-732-6754) or visit www.seaNski.com questions or commentsquestions or comments

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN2
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD2
1011849lidocaine hydrochloride 0.5 % Topical GelSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73440-2161-12023-01-30C16284748780-1f386c649-f922-0266-e053-dadaa90a7c1aCoolest Burn Relief 16oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73440-2161-1Burn Relief Gel482.46 g in 1 BOTTLEGEL482.462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73440-2161BURN RELIEF GEL (LIDOCAINE HYDROCHLORIDE) GEL [CROSS BRANDS CONTRACT FILLING]2Legacy NDC, 1 package rows20210220_bad5f763-74da-ee72-e053-2a95a90a34ce.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73440-216173440-2161-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
bbb36937-2b3f-aa2c-e053-2a95a90ac1ebbad5f763-74da-ee72-e053-2a95a90a34ce2021-02-19WarningsExact identifier
spl id: bbb36937-2b3f-aa2c-e053-2a95a90ac1eb
spl set id: bad5f763-74da-ee72-e053-2a95a90a34ce

Reported adverse events (FAERS/openFDA)#

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