ZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]

ZZIP COLD SORE TREATMENT (ALLANTOIN, DIMETHICONE, MENTHOL) SOLUTION [ZZIP AG]
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NDC 70019-100-00
Set ID cf62370a-9a10-46b1-b320-23eaf196040c
Category HUMAN OTC DRUG LABEL
Packager Zzip AG
Generic Name
Product Class
Product Number
Application Number PART348
  • Drug Facts

    ​Active Ingredients

    ​Allantoin 0.5%

    Dimethicone 1%

    Menthol 0.1%

    Purpose

    Cold sore/fever blister treatment

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  • Uses

    - Temporarily relieves the pain and itching associated with cold sores/fever blisters.

    - Temporarily protects and helps relieve chapped or cracked lips.

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  • Warnings

    For external use only

    Do not use

    - if you are allergic to any ingredient in this product

    - during pregnancy or breast-feeding.

    When using this product

    - avoid contact with eyes

    - apply only to affected areas

    - avoid applying directy inside your mouth

    - do not share this product with anyone. This may spread infection.

    - dispose cotton swab immediately after use

    - discard after 1 month of opening the tube

    Stop use and ask a doctor if

    - condition worsens

    - symptoms last more than 7 days

    - symptoms clear up and return in a few days.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    ​adults and children 12 years or over:

    - Apply to affected area on face or lips at first sign (tingle) of cold sore/fever blister

    - Open tube, saturate cotton swab with 8 drops of liquid

    - Use the cotton swab to apply to affeted area on face or lips. Do ot touch the sore with your fingers. Continue for 3 seconds until the cold sore is completely covered and sealed.

    - Dispose of cotton swab - do not reuse

    - Wash hands before and after application.

    - Apply 2 times daily, not to exceed 3 to 4 times daily until sore is healed

    ​children under 12 years: ask a doctor

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  • Other information

    Store at room temperature

    Do not freeze

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  • Inactive Ingredients

    Aloe Barbadensis, Calendula Officinalis Flower, Copper Sulfate, Demineralized water, Ethylhexylglycerin, Glycerin, Laureth-9, Maltodextrin, Opuntia Ficus Indica Stem, PEG-40 Hydrogenated CAstor Oil, Pentylene Glycol, Phenoxyethanol, Propylene Glycol, Rhododendrum Ferrugineum, Trideceth-9.

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  • Questions or comments?

    Call 1-800-257-7071 (English/Spanish) Weekdays

    Visit us at www.zzipusa.com

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  • Distributed in the USA by:

    GG Advisors, LLC

    923 Haddonfield Rd., Suite 300

    Cherry Hill, NJ 08002

    1-800-257-7071

    Switzerland developed by Zzip AG

    Made in the Netherlands

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  • Product labeling
  • INGREDIENTS AND APPEARANCE
    ZZIP COLD SORE TREATMENT 
    allantoin, dimethicone, menthol solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70019-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 5 mg  in 1 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 10 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE (UNII: V5VD430YW9)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BASIC COPPER SULFATE (UNII: CUP529P5NS)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-9 (UNII: 0AWH8BFG9A)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TRIDECETH-9 (UNII: X9HD79I514)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70019-100-00 3 mL in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/30/2015
    Labeler - Zzip AG (480040768)
    Registrant - H en L Verpakkingen B.V. (407736821)
    Establishment
    Name Address ID/FEI Business Operations
    H en L Verpakkingen B.V. 407736821 manufacture(70019-100)
    Establishment
    Name Address ID/FEI Business Operations
    Flores Natural Cosmetic 404875689 pack(70019-100)
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