Ocean Potion Ice + Pain Relieving Soothing Gel

Ocean Potion by

Drug Labeling and Warnings

Ocean Potion by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OCEAN POTION PAIN RELIEVING GEL- lidocaine hydrochloride gel 
Prime Enterprises

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Ocean Potion Ice + Pain Relieving Soothing Gel

Active Ingredients

Lidocaine Hydrochloride 0.72%

Purpose

Topical Anesthetic

Uses

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

Warnings

For exeternal use only

Do not use

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

When using this product

• avoid contact with eyes
• use only as directed

Stop use and consult a doctor if

• 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

• 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

• 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

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?

oceanpotion.com

OCEAN POTION  PAIN RELIEVING GEL
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0659
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	7.128 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MENTHOL (UNII: L7T10EIP3A)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER 980 (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0659-4	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/17/2024

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	pack(58443-0659) , analysis(58443-0659) , label(58443-0659) , manufacture(58443-0659)

Revised: 5/2024

Document Id: 18aa5557-0465-c658-e063-6394a90a555b

34390-5

Set id: 18aa5557-0464-c658-e063-6394a90a555b

Version: 1

Effective Time: 20240517