ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [HOME SMART PRODUCTS]

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  • ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [HOME SMART PRODUCTS]

ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [HOME SMART PRODUCTS]
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NDC 52862-006-03, 52862-006-04, 52862-006-06, 52862-006-09, 52862-006-10, 52862-006-11, 52862-006-12
Set ID 147174c2-854d-4fb7-b09e-2c70346a1790
Category HUMAN OTC DRUG LABEL
Packager Home Smart Products
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active ingredient (by volume)

    Isopropyl alcohol (50% concentrate)

  • PURPOSE

    Purpose

    topical antimicrobial

  • INDICATIONS & USAGE

    Uses

    • to 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 or serious burns

  • DO NOT USE

    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 of 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 ingredient

    Water, methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    HEALTH SMART ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
    TOPICAL ANTIMICROBIAL

    12 FL.OZ (354 mL)

  • PRINCIPAL DISPLAY PANEL

    alcohol-wintergreen-50

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-006
    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:52862-006-03119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    2NDC:52862-006-04178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    3NDC:52862-006-06237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    4NDC:52862-006-09295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    5NDC:52862-006-10354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    6NDC:52862-006-11414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    7NDC:52862-006-12473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2012
    Labeler - Home Smart Products (161872676)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52862-006)
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