FDA.reportPublic FDA data

Ocean Potion Ice + Pain Relieving Soothing Gel

Manufacturer
Prime Enterprises
Effective date
2024-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:02:21

Label at a glance#

ProductOcean Potion Pain Relieving Gel
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

for the temporary relief of pain and itching associated with sunburn, minor burns, minor skin irritations, scrapes, insect bites

Dosage and administration

Adults and children 2 years or older: apply to affected area not more than 3 - 4 times daily Children under 2 years of age: do not use, ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 0.72%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with sunburn, minor burns, minor skin irritations, scrapes, insect bites

Warnings

WARNINGS SECTION

For exeternal use only

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or areas with blisters

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • use only as directed

Stop use and consult a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens, or symptoms last more than 7 days
  • symptoms 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
  • Certain persons can develop allergic reactions to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years or older: apply to affected area not more than 3 - 4 times daily
  • Children under 2 years of age: do not use, ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Menthol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Sodium Hydroxide, Water, Yellow 5

Questions or comments?

OTC - QUESTIONS SECTION

oceanpotion.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display FrontPrincipal Display FrontPrincipal Display BackPrincipal Display Back

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-065958443-0659-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
MENTHOLL7T10EIP3AIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LIDOCAINE98PI200987ACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MIACT
CARBOMER 9804Q93RCW27EIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
18aa5557-0465-c658-e063-6394a90a555b18aa5557-0464-c658-e063-6394a90a555b2024-05-17WarningsExact identifier
spl id: 18aa5557-0465-c658-e063-6394a90a555b
spl set id: 18aa5557-0464-c658-e063-6394a90a555b

Reported adverse events (FAERS/openFDA)#

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