OCEAN BREEZE PAIN RELIEF- lidocaine hydrochloride cream

OCEAN BREEZE PAIN RELIEF by

Drug Labeling and Warnings

OCEAN BREEZE PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Oasis Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENT:

Lidocaine HCl 4.00%

Purpose

Topical Anesthetic

INDICATIONS:

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

WARNINGS:

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.

If swallowed, consult physician.

Do not apply 

to wounds or damaged skin.   

Do not bandage tightly.

If pregnant or breast feeding, 

contact physician prior to use.   

DIRECTIONS:

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:

Store at room temperature.

OTHER INGREDIENTS:

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:

INGREDIENTS AND APPEARANCE

OCEAN BREEZE PAIN RELIEF 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72361-332
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYALURONIC ACID (UNII: S270N0TRQY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAVENDER OIL (UNII: ZBP1YXW0H8)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
CAT'S CLAW (UNII: 9060PRM18Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72361-332-00	1 in 1 BOX	06/01/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2018

Labeler - Oasis Health, LLC (008250833)