Ckp San-40 Gel
FDA Label NDC 78235-997
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ck Polymers for the product Ckp San-40 Gel (NDC 78235-997). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Package Label.Principal Display Panel
CKP SAN-40 Gel
NDC 78235-997-40
Label-40 (Label 40 1)
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
NDC 78235-997-50
Label-50 (Label 50)
NDC 78235-997-60
Label-60 (Label 60)
NDC 78235-997-70
Label-70 (Label 70)
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