Label: AUBIO LIFE SCIENCES LIP- allantoin and lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 31, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Allantoin 0.50% (W/W)

    Lidocaine 0.50% (W/W)

  • Purpose

    skin protectant

    external analgesic

  • Uses

    • For the temporary relief of pain and Itching associated with cold sores and fever blisters
    • Relieves dryness and softens cold sores and fever blisters
  • Warnings

    For external use only

    When using this product

    • avoid contact with the eyes

    Stop use and ask a doctor

    • if condition worsens
    • if symptoms persist for more than 7 days or 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

  • Questions or comments?

    Call Toll-free 1-844-My-Aubío (1-844-692-8246)

    Weekdays 9am-5pm PT. If you are not completely satisfied, save receipt and remaining product and call us.

  • Directions

    • Wash hands before and after applying gel
    • Gently clean the affected area before applying
    • Always rub gently into affected area
    • Adults and children 2 years of age and older; apply to affected area not more than 3-4 times daily
    • Children under 2 years of age, consult a doctor
  • Inactive Ingredients

    Water (Aqua), Glycerin, Sarracenia Stalk/Flower/Seed Extract (and) Sarracenia Purpurea Leaf/Stalk/ Flower/Seed Extract, Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Flower Extract, Melissa Officinalis (Balm Mint) Extract, Dipotassium Glycyrrhizate, Phytosphingosine, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Xantham Gum, Sodium Hydroxide, Sodium Lauroyl Lactylate, Hexylene Glycol, Ethylhexylglycerin, Caprylyl Glycol, Phenoxytehanol

  • Other Information

    • Recap after each use
    • Store at room temperature
    • Protect the product in this container from excessive heat and direct sun
  • Principal Display Panel - Blister Pack Label

    Aubío™

    Cold Sore
    Treatment Gel

    External Analgesic Lip Protectant

    Ultra-effective formula with Botanicals

    Relieves pain and itch

    Cools and soothes

    NET WT 3g (0.11 oz)

    Principal Display Panel - Blister Pack Label
  • INGREDIENTS AND APPEARANCE
    AUBIO LIFE SCIENCES LIP 
    allantoin and lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70365-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mg  in 1 g
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Aloe vera Leaf (UNII: ZY81Z83H0X)  
    Carbomer Interpolymer Type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylic Alcohol (UNII: NV1779205D)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Phytosphingosine (UNII: GIN46U9Q2Q)  
    Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Ceramide NP (UNII: 4370DF050B)  
    3-Dehydroxy Ceramide 1 (UNII: CR0J8RN66K)  
    Ceramide AP (UNII: F1X8L2B00J)  
    Lavandula Angustifolia Flower (UNII: 19AH1RAF4M)  
    Melissa Officinalis (UNII: YF70189L0N)  
    Sarracenia Purpurea (UNII: FOP08H143P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70365-001-013 g in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/28/2016
    Labeler - Aubio Life Sciences LLC (080080743)
    Establishment
    NameAddressID/FEIBusiness Operations
    KLEEN CONCEPTS012989797MANUFACTURE(70365-001) , LABEL(70365-001)
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