ZYCAZIN ANTISEPTIC LIQUID (CAMPHOR, PHENOL) LIQUID [AXIS SCIENTIFIC LLC]

ZYCAZIN ANTISEPTIC LIQUID (CAMPHOR, PHENOL) LIQUID [AXIS SCIENTIFIC LLC]
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NDC 70351-101-12
Set ID 3f8b2e5a-78c5-56f2-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Axis Scientific LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredient

    Camphorated phenol (camphor 10.8% and phenol 4.7%)

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  • Purposes

    Pain reliever/antiseptic

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  • Uses

    • for temporary relief of pain associated with

    insect bites, minor burns, sunburn, minior cuts, scrapes, minor skin irritation, cold sores

    • first aid to help protect against infection in

    minor cuts, scrapes, minor burns

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  • Warnings

    For external use only

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  • Do not use

    • over large areas of the body
    • with a bandage
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  • Ask a doctor before use if you have

    • a deep or puncture wound
    • animal bites
    • serious burns
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  • When using this product

    do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

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  • Stop use and ask a doctor if

    • condition worsens
    • symptoms persis for more than 7 days or clear up and occur again within a few days
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  • Keep out of reach of children.

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

    Do not induce vomiting before contacting medical help or a Poison Control Center.

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  • Directions

    • adults and children 2 years and over:
    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • do not bandage
    • children under 2 years: ask a doctor
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  • Other information

    • store at room temperature. Avoid excessive heat above 40°C (104°F).
    • close cap tightly after use
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  • Inactive ingredients

    eucalyptus oil, light mineral oil

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  • Questions or comments?

    1-888-742-9474 (Mon - Fri 9AM - 5PM EST) or www.zycazin.com

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  • Carton

    Carton front Front of cartonBack of carton

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  • INGREDIENTS AND APPEARANCE
    ZYCAZIN ANTISEPTIC LIQUID 
    camphor, phenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70351-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 10.8 mg  in 100 mL
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 4.7 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70351-101-12 1 in 1 CARTON 11/01/2016
    1 12 mL in 1 BOTTLE; 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 11/01/2016
    Labeler - Axis Scientific LLC (057647986)
    Establishment
    Name Address ID/FEI Business Operations
    Axis Scientific LLC 057647986 pack(70351-101) , manufacture(70351-101) , label(70351-101)
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