Otc - Active Ingredient
Active Ingredients:
Isopropyl Alcohol USP, 70% v/v
Sterile Alcohol Prep Pad
FDA Label NDC 68113-720
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Caribbean Medical Brokers for the product Sterile Alcohol Prep Pad (NDC 68113-720). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, general precautions, otc - do not use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Use: For preparation of skin prior to an injection to decrease germs in minor cuts and scrapes.
Warnings
Warnings: For external use only.
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.
General Precautions
Caution: Do not apply to irritated skin.
Otc - Do Not Use
Do not use in the eyes or on mucous membranes. In case of deep or puncture wounds, consult a doctor.
Dosage & Administration
Directions: Wipe injection site vigorously.
Storage And Handling
Other information: Store at room temperature.
Inactive Ingredient
Inactive Ingredients: Water
Other
Manufactured by:
Specialty Medical Supplies
Coral Springs, FL 33065
954-752-5603
www.specialtymedicalsupplies.com
Made in China
Package Label.Principal Display Panel
200 Individual Pads
NDC: 68113-720-02
Specialty Medical Supplies
Alcohol Prep Pads
*Sterile - Medium
Antiseptic for preparation of the skin prior to injection
For Individual, Professional, and Hospital Use
Saturated with 70% v/v Isopropyl Alcohol for external use only
*Sterile in unopened, undamaged package.
Sterile Prep Pad Labeling.jpgSterile Prep Pad Labeling.jpg
* Please review the disclaimer below.
