FDA.reportPublic FDA data

Tinfu Isopropyl Alcohol Prep Pads

Manufacturer
Shandong T&F Medical Technology Co., Ltd | Shandong T&F Medical Technology Co., Ltd.
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:16

Label at a glance#

ProductTinfu Isopropyl Alcohol Prep Pads
Active ingredientISOPROPYL ALCOHOL
Label structure14 sections

Dosage and administration

Apply to skin as needed. Discard after single use.

Storage and handling

Store at room temperature 15-30C (59-86F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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. Isopropyl Alcohol (75%, 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)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol, 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For preparation of the skin prior to injection.

Warnings

WARNINGS SECTION

For external use only. Flammable,keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • with electrocautery procedures.

OTC - WHEN USING SECTION

When using this product do not get into 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. use only in a well ventilated area.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develops.

FEMALES & MALES OF REPRODUCTIVE POTENTIAL SECTION

If pregnant or breastfeeding ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to skin as needed.
  • Discard after single use.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature 15-30C (59-86F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82167-000

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN3
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD3
797544isopropyl alcohol 70 % Medicated PadSY3
797544isopropyl alcohol 70 % Topical ClothSY3
797544isopropyl alcohol 70 % Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82167-000-012026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-022026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-032026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-042026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-052026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-062026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-072026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-082026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-092026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-102026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-112026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556
82167-000-122026-01-29C16284748780-149896155-b190-586f-e063-e6dba90add90ca5006ec-1f43-c310-e053-2995a90a2556

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82167-000-01Tinfu Isopropyl Alcohol Prep Pads0.12 mL in 1 PATCHCLOTH0.123
82167-000-02Tinfu Isopropyl Alcohol Prep Pads100 in 1 BOXCLOTH1003
82167-000-02Tinfu Isopropyl Alcohol Prep Pads0.12 mL in 1 PACKETCLOTH0.123
82167-000-03Tinfu Isopropyl Alcohol Prep Pads200 in 1 BOXCLOTH2003
82167-000-03Tinfu Isopropyl Alcohol Prep Pads0.12 mL in 1 PACKETCLOTH0.123
82167-000-04Tinfu Isopropyl Alcohol Prep Pads0.12 mL in 1 PACKETCLOTH0.123
82167-000-04Tinfu Isopropyl Alcohol Prep Pads300 in 1 BOXCLOTH3003
82167-000-05Tinfu Isopropyl Alcohol Prep Pads0.25 mL in 1 PATCHCLOTH0.253
82167-000-06Tinfu Isopropyl Alcohol Prep Pads100 in 1 BOXCLOTH1003
82167-000-06Tinfu Isopropyl Alcohol Prep Pads0.25 mL in 1 PACKETCLOTH0.253
82167-000-07Tinfu Isopropyl Alcohol Prep Pads0.25 mL in 1 PACKETCLOTH0.253
82167-000-07Tinfu Isopropyl Alcohol Prep Pads200 in 1 BOXCLOTH2003
82167-000-08Tinfu Isopropyl Alcohol Prep Pads300 in 1 BOXCLOTH3003
82167-000-08Tinfu Isopropyl Alcohol Prep Pads0.25 mL in 1 PACKETCLOTH0.253
82167-000-09Tinfu Isopropyl Alcohol Prep Pads0.56 mL in 1 PATCHCLOTH0.563
82167-000-10Tinfu Isopropyl Alcohol Prep Pads0.56 mL in 1 PACKETCLOTH0.563
82167-000-10Tinfu Isopropyl Alcohol Prep Pads100 in 1 BOXCLOTH1003
82167-000-11Tinfu Isopropyl Alcohol Prep Pads200 in 1 BOXCLOTH2003
82167-000-11Tinfu Isopropyl Alcohol Prep Pads0.56 mL in 1 PACKETCLOTH0.563
82167-000-12Tinfu Isopropyl Alcohol Prep Pads300 in 1 BOXCLOTH3003
82167-000-12Tinfu Isopropyl Alcohol Prep Pads0.56 mL in 1 PACKETCLOTH0.563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82167-000TINFU ISOPROPYL ALCOHOL PREP PADS (ISOPROPYL ALCOHOL) CLOTH [SHANDONG T&F MEDICAL TECHNOLOGY CO., LTD]3Legacy NDC, 21 package rows20231116_ca5006ec-1f43-c310-e053-2995a90a2556.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82167-00082167-000-01, 82167-000-02, 82167-000-03, 82167-000-04, 82167-000-05, 82167-000-06, 82167-000-07, 82167-000-08, 82167-000-09, 82167-000-10, 82167-000-11, 82167-000-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0a2c3f15-32a3-ac35-e063-6294a90a1213ca5006ec-1f43-c310-e053-2995a90a25562023-11-15WarningsExact identifier
spl id: 0a2c3f15-32a3-ac35-e063-6294a90a1213
spl set id: ca5006ec-1f43-c310-e053-2995a90a2556

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.