ASSURED

Manufacturer
INDELPA, S.A. DE C.V.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:46:40

Label at a glance#

ProductASSURED
Active ingredientBENZALKONIUM CHLORIDE
Label structure16 sections

Storage and handling

Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.125%

OTC - PURPOSE SECTION

Antibacterial

USE

INDICATIONS & USAGE SECTION

Decreases bacteria on skin.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

If you are allergic to any of the ingredients

OTC - WHEN USING SECTION

Do not get into eyes.

If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

If irritation or rash develops and continues for more than 72 hours

OTC - ASK DOCTOR SECTION

If irritation or rash develops and continues for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center rigth away.

INDICATIONS & USAGE SECTION

  • Thoroughly wipe hands and face as desired.
  • Allow to dry without wiping.
  • Discard wipe in trash receptacle after use.
  • Do not flush.

INSTRUCTIONS FOR USE SECTION

To dispense wipe: Peel back front label slowly. Remove wipes.

To reseal pouch: Firmly run thumb over the label.

STORAGE AND HANDLING SECTION

Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Fragrance, Citric Acid, Vitamin E, Methylchloroisothiazolinone, Aloe Extract, Tetrasodium EDTA.

DOSAGE & ADMINISTRATION SECTION

Dosage: Swab

Administration: Topical

SUMMARY OF SAFETY AND EFFECTIVENESS

Assured TM Antibacterial Wet Wipes kills germs and bacteria, cleans and freshens your skin and gently wipes away perspiration and odor.

With moisturizing formula containing Aloe Vera and Vitamin E, Assured TM Antibacterial Wet Wipes are soft and gentle, and helping to nourish your skin as you freshen up.

This travel pack is convenitent to take along for use anytime or anywhere.

ASSURED
Antibacterial
Wet Wipes
Hand & face moisturizing towelettes

For hands and face
Ideal for travling
Moisturizing
Thick and soft cloths
Fresh scent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL WATERFALLLABEL WATERFALLWATERFALLWATERFALLASSURED ANTIBACTERIAL WIPES 3X10ASSURED ANTIBACTERIAL WIPES 3X10

ANTIBACTERIAL 15 COUNTANTIBACTERIAL 15 COUNT

INNER ANIBACTERIAL 15 COUNTINNER ANIBACTERIAL 15 COUNT

ANTIBACTERIAL 20 COUNTANTIBACTERIAL 20 COUNT

ANTIBACTERIAL 40 COUNTANTIBACTERIAL 40 COUNT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2276303benzalkonium Cl 0.125 % Medicated PadPSN8
2276303benzalkonium chloride 1.25 MG/ML Medicated PadSCD8
2276303benzalkonium chloride 0.125 % Medicated WipeSY8
2276303benzalkonium chloride 0.125 % Topical ClothSY8
2276303benzalkonium chloride 0.125 % Topical SwabSY8

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70697-800-03ASSURED3 in 1 BAGSWAB38
70697-800-03ASSURED10 in 1 PACKAGESWAB108
70697-800-04ASSURED40 in 1 PACKAGESWAB408
70697-800-04ASSURED0.375 mg in 1 POUCHSWAB0.3758
70697-800-05ASSURED0.375 mg in 1 POUCHSWAB0.3758
70697-800-05ASSURED20 in 1 PACKAGESWAB208
70697-800-06ASSURED2 in 1 PACKAGESWAB28
70697-800-06ASSURED15 in 1 PACKAGESWAB158
70697-800-07ASSURED12 in 1 CASESWAB128
70697-800-07ASSURED103.2 mg in 1 POUCHSWAB103.28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70697-800ASSURED (BENZALKONIUM CHLORIDE) SWAB [INDELPA, S.A. DE C.V.]8Legacy NDC, 10 package rows20220114_317f63af-9696-6bef-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70697-80070697-800-03, 70697-800-04, 70697-800-05, 70697-800-06, 70697-800-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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
d57bb3c4-9079-5727-e053-2995a90a8f94317f63af-9696-6bef-e054-00144ff8d46c2022-01-13WarningsExact identifier
spl id: d57bb3c4-9079-5727-e053-2995a90a8f94
spl set id: 317f63af-9696-6bef-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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