FDA.reportPublic FDA data

OCEAN BREEZE PAIN RELIEF CREAM

Manufacturer
Oasis Health, LLC
Effective date
2018-06-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:55:23

Label at a glance#

ProductOCEAN BREEZE PAIN RELIEF
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Dosage and administration

• Adults and children twelve-years of age or older: Apply to affected area not more than three to four times daily. • Children under twelve-years of age: consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4.00%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

WARNINGS:

WARNINGS SECTION

• For external use only.

• Avoid contact with eyes
• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Do not apply 

OTC - DO NOT USE SECTION

• to wounds or damaged skin.   

• Do not bandage tightly.

If pregnant or breast feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.   

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Adults and children twelve-years of age or older: Apply to affected area not more than three to four times daily.
• Children under twelve-years of age: consult a physician.

ADDITIONAL INFORMATION:

SPL UNCLASSIFIED SECTION

Store at room temperature.

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Hyaluronic Acid, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine, Uncaria Tomentosa (Cat’s Claw) Extract.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72361-33272361-332-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CETYL ALCOHOL936JST6JCNIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYALURONIC ACIDS270N0TRQYIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAVENDER OILZBP1YXW0H8IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
CAT'S CLAW9060PRM18QIACT
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
0749468a-c481-21be-e063-6294a90a35e5b125b3aa-9b83-45d1-bcb9-2123f3e627532023-10-09WarningsExact identifier
spl set id: b125b3aa-9b83-45d1-bcb9-2123f3e62753

Reported adverse events (FAERS/openFDA)#

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