SYREN INTIMATE RELIEF TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [ICON HEALTH SCIENCE]

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SYREN INTIMATE RELIEF TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [ICON HEALTH SCIENCE]
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NDC 69233-843-01
Set ID 57d5a080-3583-4510-e053-2a91aa0ad589
Category HUMAN OTC DRUG LABEL
Packager Icon Health Science
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • DRUG FACTS

  • Active Ingredient:

    Lidocaine HCl 4.00%

    Topical Analgesic

  • Indications:

    For the temporary relief of pain and itching, cuts, scrapes, and minor skin irritations.

  • Warnings:

    • For external use only.
    • Avoid contact with eyes.
    • If symptoms persist for more than seven days discontinue use.

    Keep out of reach of children.

    If swallowed, consult physician.

    • Do not apply to wounds or damaged skin.
    • Wash hands after use.

    If pregnant or breast feeding, contact physician prior to use.

  • Directions:

    • Adults and children two-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:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Benzoic Acid, Cannabis Sativus (Hemp) Seed Oil, Carbomer, Carrageenan, Ethylhexylglycerin, I-Arginine, PEG-8, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Tocopherol Acetate (Vitamin E), Triethanolamine.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SYREN INTIMATE RELIEF TOPICAL PAIN RELIEF 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69233-843
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69233-843-011 in 1 BOX08/28/2017
    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 finalpart34808/28/2017
    Labeler - Icon Health Science (079435759)
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