50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [AMERICAN CONSUMER PRODUCTS LLC]

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  • 50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [AMERICAN CONSUMER PRODUCTS LLC]

50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [AMERICAN CONSUMER PRODUCTS LLC]
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NDC 18027-003-01, 18027-003-02, 18027-003-03, 18027-003-04, 18027-003-05, 18027-003-06, 18027-003-07
Set ID 34dd1ec5-2404-4c94-981d-176bc53cebbb
Category HUMAN OTC DRUG LABEL
Packager AMERICAN CONSUMER PRODUCTS LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active Ingredient (by volume)

    Isopropyl alcohol (50% conc.)

  • PURPOSE

    Purpose

    Topical Antimicrobial

  • INDICATIONS & USAGE

    Uses

    • decrease germs in minor cuts and scrapes.
    • helps relieve minor muscular aches due to exertion.
  • WARNINGS

    Warnings

    For external use only

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if taken internally.
  • ASK DOCTOR

    Ask a doctor before use if you have deep puncture wounds serious burns

  • WHEN USING

    When using this product

    • do not get into eyes or mucous membranes
    • use only in a well-ventilated area
  • STOP USE

    Stop use and ask a doctor if condition persists or gets worse.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply to skin directly or with clean gauze, cotton or swab
    • for rubbing, apply liberally and rub with hands
  • SPL UNCLASSIFIED SECTION

    Other information

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
    • keep bottle tightly closed
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (Aqua), Methyl Salicylate, Laneth-75, FD&C Blue #1, FD&C Yellow #5

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGEEN

    Topical Antimicrobial

    12 FL.OZ (354 mL)

    label2

  • INGREDIENTS AND APPEARANCE
    50% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:18027-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:18027-003-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
    2NDC:18027-003-02177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
    3NDC:18027-003-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
    4NDC:18027-003-04296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
    5NDC:18027-003-05354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
    6NDC:18027-003-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
    7NDC:18027-003-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2017
    Labeler - AMERICAN CONSUMER PRODUCTS LLC (858427334)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(18027-003)
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