ISO BLU 50 PERCENT (ISOPROPYL ALCOHOL) LIQUID [P & L DEVELOPMENT, LLC]

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ISO BLU 50 PERCENT (ISOPROPYL ALCOHOL) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0269-6
Set ID c80f1bf4-0fa8-4dfb-b99b-7b9646afd0ad
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active ingredient (by volume)

    Isopropyl alcohol (50% conc)

  • Purpose

    first aid antiseptic

  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • Warnings

    For external use only.

    • flammable, keep away from fire or flame
    • if taken internally serious gastric disturbances will result

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body
    • do not use longer than one week unless directed by a doctor

    Stop use and ask a doctor if

    • condition persists or gets worse

    Keep out of reach of children.

    In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • clean affected area
    • apply small amount of this product on the area 1-3 times daily
    • if bandaged, let dry first
    • may be covered with a sterile bandage
  • Other information

    • store at room temperature
    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • Inactive ingredients

    camphor, eucalyptus, FD&C blue #1, glycerin, menthol, purified water

  • Principal Display Panel

    50% Iso-Blu®

    Topical Analgesic

    Isopropyl Alcohol

    Menthol

    Eucalyptus

    Camphor

    Fast temporary pain relief for

    aches

    soreness

    strains

    Warning: Flammable, keep away from spark, heat or flame

    Manufactured by: PL Developments

    1874 Hwy 72 W

    clinton, SC 29325

    Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP PRINTED SAFETY FOIL IS BROKEN OR MISSING.

  • Package Label

    Isopropyl alcohol 50%

    %0 Percent Iso-Blu

  • INGREDIENTS AND APPEARANCE
    ISO BLU  50 PERCENT
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0269-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/201512/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/31/201512/30/2021
    Labeler - P & L Development, LLC (101896231)
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