OCEAN BREEZE PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [OASIS HEALTH, LLC]

  • Home
  • OCEAN BREEZE PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [OASIS HEALTH, LLC]

OCEAN BREEZE PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [OASIS HEALTH, LLC]
PDF | XML
NDC 72361-332-00
Set ID b125b3aa-9b83-45d1-bcb9-2123f3e62753
Category HUMAN OTC DRUG LABEL
Packager Oasis Health, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
View All Sections
  • 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:

    Label

  • INGREDIENTS AND APPEARANCE
    OCEAN BREEZE PAIN RELIEF 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72361-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72361-332-001 in 1 BOX06/01/2018
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2018
    Labeler - Oasis Health, LLC (008250833)
View All Sections

Related Drugs

Search DailyMed Drugs