FDA.reportPublic FDA data

Hand Sanitizing and Moisturizing Wipes

Manufacturer
Generic Specialties, Inc.
Effective date
2020-09-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:48

Label at a glance#

ProductHand Sanitizing and Moisturizing Wipes
Active ingredientISOPROPYL ALCOHOL
Label structure14 sections

Dosage and administration

Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizing & moisturizing wipes 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 sanitizing & moisturizing wipes are 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:

Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (67%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin

Sodium EDTA

PEG 40 Hydrogenated Castor Oil

Fragrance
Aqua.

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 67% v/v. Purpose: Antimicrobial, Antibacterial

Purpose

OTC - PURPOSE SECTION

Antimicrobial, Antibacterial Hand sanitizing and moisturizing wipes

Use

INDICATIONS & USAGE SECTION

Hand Sanitizing wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 injured or irritated skin
  • If you are sensitive to any of its ingredients

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 at 1-800-222-1222

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Sodium EDTA, PEG 40 Hydrogenated Castor Oil, Fragrance

RECENT MAJOR CHANGES SECTION

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease. for use when soap and water are not available.

Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

202030306060160160180180

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78985-002-092022-01-28C16284748780-1d6a99b39-4823-a426-e053-dadaa90af4c2b021df64-b9ff-13a2-e053-2a95a90af28e
78985-002-112022-01-28C16284748780-1d6a99b39-4823-a426-e053-dadaa90af4c2b021df64-b9ff-13a2-e053-2a95a90af28e
78985-002-182022-01-28C16284748780-1d6a99b39-4823-a426-e053-dadaa90af4c2b021df64-b9ff-13a2-e053-2a95a90af28e
78985-002-192022-01-28C16284748780-1d6a99b39-4823-a426-e053-dadaa90af4c2b021df64-b9ff-13a2-e053-2a95a90af28e
78985-002-202022-01-28C16284748780-1d6a99b39-4823-a426-e053-dadaa90af4c2b021df64-b9ff-13a2-e053-2a95a90af28e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78985-002-09Hand Sanitizing and Moisturizing Wipes30 in 1 POUCHSWAB301
78985-002-11Hand Sanitizing and Moisturizing Wipes60 in 1 POUCHSWAB601
78985-002-18Hand Sanitizing and Moisturizing Wipes180 in 1 CANISTERSWAB1801
78985-002-19Hand Sanitizing and Moisturizing Wipes20 in 1 POUCHSWAB201
78985-002-20Hand Sanitizing and Moisturizing Wipes160 in 1 CANISTERSWAB1601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78985-002HAND SANITIZING AND MOISTURIZING WIPES (ISOPROPYL ALCOHOL) SWAB [GENERIC SPECIALTIES, INC.]1Legacy NDC, 5 package rows20201002_b021df64-b9ff-13a2-e053-2a95a90af28e.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78985-00278985-002-11, 78985-002-18, 78985-002-19, 78985-002-09, 78985-002-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EDETATE SODIUMMP1J8420LUIACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
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
b021dfa9-f049-7163-e053-2995a90a8cbbb021df64-b9ff-13a2-e053-2a95a90af28e2020-09-17WarningsExact identifier
spl id: b021dfa9-f049-7163-e053-2995a90a8cbb
spl set id: b021df64-b9ff-13a2-e053-2a95a90af28e

Reported adverse events (FAERS/openFDA)#

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