CKP SAN-4I LIQ- alcohol solution 
CK Polymers

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.

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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

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 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.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

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

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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

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NDC: 78235-996-61

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NDC: 78235-996-71

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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)

Revised: 7/2020
Document Id: 95aaab2f-9c1f-4dbc-9f2c-676605aa6a45
Set id: 1c2442c3-24eb-4b65-b282-693b90895cb0
Version: 4
Effective Time: 20200702
 
CK Polymers