FDA.reportPublic FDA data

Colemerg Premium Sanitizing Wipes

Manufacturer
KSMT COMPANY INCORPORATED
Effective date
2021-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:14

Label at a glance#

ProductColemerg Premium Sanitizing Wipes
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

When water, soap and towel are not availble. Recommended for repeated use. 

Dosage and administration

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • When water, soap and towel are not availble.
  • Recommended for repeated use. 

Warnings

WARNINGS SECTION

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

When Using This Product:

OTC - WHEN USING SECTION

  • Do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.
  • use wipes only on unbroken intact skin.
  • if you have sensitive skin or certain allergies, check the list of ingredients on the label before using wipes.
  • Do not ingest.

stop use and ask a doctor:

OTC - STOP USE SECTION

If skin irritation or redness develops.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 6 years of age use only under adult supervision.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Not recommended for infants.

Other Information:

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua/Water, Glycerin, Propylene Glycol, Fragrance, Sodium PCA, Disodium EDTA.

Package Labeling:80 wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

Package Labeling: 160 wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label160Label160

Package Labeling:500 wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label500Label500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN2
1307051ethanol 0.75 ML/ML Medicated PadSCD2
1307051ethanol 75 % Hand Sanitizer WipesSY2
1307051ethyl alcohol 75 % Topical ClothSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81547-000-012023-01-30C16284748780-1f386c64a-2a11-0266-e053-dadaa90a7c1aColemerg Premium Sanitizing Wipes, 80 Alcohol wipes
81547-000-022023-01-30C16284748780-1f386c64a-2a11-0266-e053-dadaa90a7c1aColemerg Premium Sanitizing Wipes, 80 Alcohol wipes
81547-000-032023-01-30C16284748780-1f386c64a-2a11-0266-e053-dadaa90a7c1aColemerg Premium Sanitizing Wipes, 80 Alcohol wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81547-000-01Colemerg Premium Sanitizing Wipes80 in 1 CANISTERCLOTH802
81547-000-01Colemerg Premium Sanitizing Wipes3.2 mL in 1 PATCHCLOTH3.22
81547-000-02Colemerg Premium Sanitizing Wipes3.2 mL in 1 PATCHCLOTH3.22
81547-000-02Colemerg Premium Sanitizing Wipes160 in 1 CANISTERCLOTH1602
81547-000-03Colemerg Premium Sanitizing Wipes500 in 1 CANISTERCLOTH5002
81547-000-03Colemerg Premium Sanitizing Wipes3.2 mL in 1 PATCHCLOTH3.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81547-000COLEMERG PREMIUM SANITIZING WIPES (ALCOHOL) CLOTH [KSMT COMPANY INCORPORATED]2Legacy NDC, 6 package rows20210220_94f91970-6fc4-46ac-9e5d-43bfcc3195a5.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81547-00081547-000-01, 81547-000-02, 81547-000-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALCOHOL3K9958V90MACTIB

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
bbb32a8f-12d3-a3c4-e053-2a95a90aa07694f91970-6fc4-46ac-9e5d-43bfcc3195a52021-02-19WarningsExact identifier
spl id: bbb32a8f-12d3-a3c4-e053-2a95a90aa076
spl set id: 94f91970-6fc4-46ac-9e5d-43bfcc3195a5

Reported adverse events (FAERS/openFDA)#

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