Label: ISOPROPYL RUBBING ALCOHOL 99%- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 26, 2020

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  • ACTIVE INGREDIENT

    Active ingredient (by volume)

    Isopropyl alcohol (99% 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

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    HEALTH SMART ISOPROPYL RUBBING ALCOHOL 99%

    TOPICAL ANTIMICROBIAL

    12 FL.OZ (354 mL)

  • PRINCIPAL DISPLAY PANEL

    alcohol-99

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 99% 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL99 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-027-03119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
    2NDC:52862-027-04178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
    3NDC:52862-027-06237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
    4NDC:52862-027-09295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
    5NDC:52862-027-10354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
    6NDC:52862-027-11414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
    7NDC:52862-027-12473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/18/2020
    Labeler - Home Smart Products (161872676)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-027)
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