PAINZONE (EXTERNAL ANALGESIC) CREAM [MEDZONE PRODUCTS LLC]

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PAINZONE (EXTERNAL ANALGESIC) CREAM [MEDZONE PRODUCTS LLC]
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NDC 70338-641-10, 70338-641-12, 70338-641-30
Set ID 3773fe01-2206-206c-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager MedZone Products LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Camphor 3%

    Menthol 12%

    Methyl Salicylate 20%

  • Purpose

    Analgesic

    Counterirritant

    Counterirritant

  • Uses

    Temporarily relieves minor aches and pains of muscle and joints associated with strains, sprains, arthritis, simple backache.

    Provides pentrating pain relief.

  • Warnings

    For external use only.Back panel

    When using this product

    • do not get into eyes

    Stop use and ask a physician if

    • Allergic reaction occurs
    • Condition worsens or does not improve within 7 days
    • Symptoms clear up and return within a few days
    • Redness, irritation, swelling, pain or other symptoms begin or increase

    Do not

    • Use in or near the eyes
    • Use in large quantities, particularly over raw surfaces or blistered areas

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

  • Other Information

    Store at room temperature. Avoid excessive heat or cold.

  • Inactive Ingredients

    Aloe Vera Leaf, Glycerin, Jojoba Oil, Oleic Acid, Polyethylene Glycol 400, Silica, Tea Tree Oil

  • Questions?

    Toll-Free 866-MEDZONE (866-633-9663)

    www.medzonecorp.com info@medzonecorp.com

  • HOW SUPPLIED

    Distributed by MedZone Products LLC

    Lenexa, Kansas 66215 All Rights Reserved

  • PRINCIPAL DISPLAY PANEL

    3 oz label1 oz label 1 oz label

  • INGREDIENTS AND APPEARANCE
    PAINZONE 
    external analgesic cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-641
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-30 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL120 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70338-641-123.6 g in 1 POUCH; Type 0: Not a Combination Product07/01/2016
    2NDC:70338-641-3088 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/30/2016
    3NDC:70338-641-1028 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2016
    Labeler - MedZone Products LLC (080083739)
    Registrant - Richard Hamer Associates LLC (067731889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biomed Laboratories LLC055329696pack(70338-641) , manufacture(70338-641)
    Establishment
    NameAddressID/FEIBusiness Operations
    MicroConsult Inc062183608analysis(70338-641)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ceutical Laboratories Inc789485153analysis(70338-641)
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