FDA Label for Ckp San-4i Liq
View Indications, Usage & Precautions
Ckp San-4i Liq Product Label
The following document was submitted to the FDA by the labeler of this product Ck Polymers. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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
Otc - 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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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: 00000-000-00
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 States1-713-979-3970
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
* Please review the disclaimer below.