Label: CARE1 ISOPROPYL RUBBING ALCOHOL 72%- 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 October 1, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Isopropyl Alcohol 72% v/v. Purpose: Antiseptic

  • Purpose

    First aid antiseptic

  • Use

    Helps prevent the risk of infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Ask a doctor before use

    for deep wounds, animal bites or serious burns

  • WHEN USING

    •do not get into eyes

    • do not apply over large area of the body

    • do not use longer than 1 week

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area

    • apply 1 to 3 times daily

  • Other information

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol

    • will produce serious gastric disturbances if taken internally

  • Inactive ingredients

    Purified water USP

  • Package Label - Principal Display Panel

    473 ml NDC: 78975-505-05 473ml NDC: 78975-505-05

  • INGREDIENTS AND APPEARANCE
    CARE1 ISOPROPYL RUBBING ALCOHOL 72% 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78975-505
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78975-505-05473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/02/2020
    Labeler - Lauree LLC (102938225)
    Registrant - Care 1 (066368393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lauree LLC102938225manufacture(78975-505)
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