ServClean Sanitizing Wipes

Manufacturer
Charlotte Products Ltd. | Charlotte Products Ltd
Effective date
2021-02-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:56

Label at a glance#

ProductServClean Sanitizing Wipes
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

Open the plastic tab at the front of the bottle. Pull up wipe and replace plastic cap. Always snap lid securely shut between uses to prevent moisture loss. • Take one wipe and rub onto hands to cover all surfaces. Let hands air dry. • NOT intended for intimate hygiene. Dispose of used wipes in trash. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store at room temperature in a cool, dry place, avoid direct sunlight. Store below 110°F (43°C). Do not reuse empty canister.

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: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Personal hand sanitizing wipe to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Open the plastic tab at the front of the bottle. Pull up wipe and replace plastic cap. Always snap lid securely shut between uses to prevent moisture loss.

• Take one wipe and rub onto hands to cover all surfaces. Let hands air dry.

• NOT intended for intimate hygiene. Dispose of used wipes in trash.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Storage

STORAGE AND HANDLING SECTION

Store at room temperature in a cool, dry place, avoid direct sunlight. Store below 110°F (43°C). Do not reuse empty canister.

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70 Count NDC: 64646-399-01

ServClean Wipes 70ServClean Wipes 70

180 Count NDC: 64646-399-02

ServClean Wipes 180ServClean Wipes 180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD1
797544isopropyl alcohol 70 % Medicated PadSY1
797544isopropyl alcohol 70 % Topical ClothSY1
797544isopropyl alcohol 70 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64646-399-012023-01-30C16284748780-1f386c64a-3e03-0266-e053-dadaa90a7c1aServClean Sanitizing Wipes
64646-399-022023-01-30C16284748780-1f386c64a-3e03-0266-e053-dadaa90a7c1aServClean Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-399-01ServClean Sanitizing Wipes343 mL in 1 CANISTERCLOTH3431
64646-399-02ServClean Sanitizing Wipes1000 mL in 1 CANISTERCLOTH10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-399SERVCLEAN SANITIZING WIPES (ISOPROPYL ALCOHOL) CLOTH [CHARLOTTE PRODUCTS LTD.]1Legacy NDC, 2 package rows20210210_bad457c3-8e51-6598-e053-2995a90abe48.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
64646-39964646-399-01, 64646-399-02

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
bad457c3-8e43-6598-e053-2995a90abe48bad457c3-8e51-6598-e053-2995a90abe482021-02-08WarningsExact identifier
spl id: bad457c3-8e43-6598-e053-2995a90abe48
spl set id: bad457c3-8e51-6598-e053-2995a90abe48

Reported adverse events (FAERS/openFDA)#

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