Label: CKP SAN-4I LIQ- alcohol solution

  • 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 July 2, 2020

If you are a consumer or patient please visit this version.

  • 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    1 L (1000 mL) NDC: 78235-996-41

    label-41

    MANUFACTURER:

    United States

    CK Polymers, LLC

    4801 Woodway Drive

    Suite 275E

    Houston, TX 77056

    ​EMERGENCY PHONE:

    ​United States

    CHEMTREC

    1-800-424-9300 (24 hours)

    ​BUSINESS PHONE:

    ​​United States

    ​1-713-979-3970

    ​LABELING AND CLASSIFICATIONS:

    ​Classification of the substance or mixture according to Hazardous Communication Standard, 29 CFR 1910.1200:

    Eye irritation, category 2A

    Flammable liquids, category 2

    ​Signal word: ​Danger

    ​Hazard-determining components of labeling:

    ​Ethanol

    ​HAZARD STATEMENTS:

    ​H224 Highly flammable liquid and vapor

    H319 Causes serious eye irritation

    ​PRECAUTIONARY STATEMENTS:

    ​P210 Keep away from heat/sparks/open flames/hot surfaces. No smoking

    P233 Keep container tightly closed

    P240 Ground/bond container and receiving equipment

    P241 Use explosion-proof electrical/ventilating/lighting/equipment

    P242 Use only non-sparking tools

    P243 Take precautionary measures against static discharge

    P264 Wash hands thoroughly after handling

    P280 Wear protective gloves/protective clothing/eye protection/face protection

    P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.

    P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing

    P337+P313 If eye irritation persists: Get medical advice/attention

    P370+P378 In case of fire: Use agents recommended in section 5 to extinguish

    P403+P235 Store in a well-ventilated place. Keep cool

    P501 Dispose of contents/container in accordance with local regulations.

    ​TRANSPORTATION:

    UN Number: 1170

    Proper shipping name: Ethanol Solution

    Packing group: II

    Hazard class: 3

    California Proposition 65: None of the ingredients are listed.

    Refer to the SDS for full guidelines and product information

    Generated using Total SDS (patent-pending), www.GSMSDS.com

    NDC: 78235-996-51

    label-51

    NDC: 78235-996-61

    label-61

    NDC: 78235-996-71

    label-71

  • INGREDIENTS AND APPEARANCE
    CKP SAN-4I LIQ 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78235-996
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 L  in 100 L
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L  in 100 L
    WATER (UNII: 059QF0KO0R) 18.425 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78235-996-311249.19 L in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
    2NDC:78235-996-513.78541 L in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    3NDC:78235-996-6118.9271 L in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    4NDC:78235-996-71208.198 L in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/29/2020
    Labeler - CK Polymers (079790285)
    Establishment
    NameAddressID/FEIBusiness Operations
    CK Polymers079790285manufacture(78235-996)