Alcohol Prep Pads
76162-808 TopCare IPA Prep Pads
Approved
Approval ID
2642298f-607e-fdca-e063-6394a90a69d9
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 22, 2025
Manufacturers
FDA
Topco Associates
DUNS: 006935977
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isopropyl Alcohol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76162-808
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: ND2M416302
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/5/2024
Package label
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 12/5/2024
Uses
- For preparation of the skin prior to injection
- First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/5/2024
Active Ingredient
Isopropyl alcohol, 70% v/v
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 12/5/2024
Purpose
Antiseptic
WARNINGS SECTION
LOINC: 34071-1Updated: 12/5/2024
Warnings
For external use only. Flammable, keep away from fire or flame.
Do not use
- With electrocautery procedures.
- Longer than one week unless directed by a physician.
When using this product
- Do not get in eyes.
- Do not apply over large areas of the body.
- In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.
Stop use and ask a doctor if
- Irritation and redness develop.
- Condition gets worse or persists for more than 72 hours.
Keep out of reach of children
If accidentally swallowed, seek medical assistance or immediately contact a Poison Control Center.
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 12/5/2024
Directions
- Apply to skin as needed.
- Discard after single use.
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 12/5/2024
Other information
- Protect from freezing and avoid excessive heat.
- Not made with Natural Rubber Latex.
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 12/5/2024
Inactive ingredients
water
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 12/5/2024
Manufacturer information
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO MDLA1024
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com
PACKAGED IN CHINA WITH COMPONENTS FROM TAIWAN
REF TOP090734V2 V1 RK24SXM