FDA.reportPublic FDA data

WE CARE Sanitizing Wipe

Manufacturer
Guangzhou Baihua Co., Ltd. | Guangzhou Baihua Co., Ltd
Effective date
2021-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:42

Label at a glance#

ProductWE CARE Sanitizing Wipe
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Thoroughly wipe hands, fingers and wrists. Supervise children under 6 years of age when using this product.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) Dispose of wipes in trash after use. Do not flush.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Antiseptic, WE CARE Sanitizing Wipes

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

SPL UNCLASSIFIED SECTION

This is a sanitizing wipe 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 sanitizing wipe 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (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.

Use

INDICATIONS & USAGE SECTION

Alcohol Sanitizing Wipes to help reduce bacteria on skin. 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 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 occurs. This may be sign 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

  • Thoroughly wipe hands, fingers and wrists.
  • Supervise children under 6 years of age when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • Dispose of wipes in trash after use. Do not flush.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, RO pure water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WE CARE wipe 1pc NDC: 77665-103-01

WE CARE Sanitizing Wipe 1pc LabelWE CARE Sanitizing Wipe 1pc Label

50 wipes NDC: 77665-101-01 50 wipes label50 wipes label

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
77665-103-012023-01-30C16284748780-1f386c649-b640-0266-e053-dadaa90a7c1aac026e73-463a-67b7-e053-2a95a90a7f9d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77665-103-01WE CARE Sanitizing Wipe1 mL in 1 PACKAGECLOTH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77665-103WE CARE SANITIZING WIPE (ALCOHOL) CLOTH [GUANGZHOU BAIHUA CO., LTD.]2Legacy NDC, 1 package rows20211217_ac026e73-463a-67b7-e053-2a95a90a7f9d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77665-10377665-103-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
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
d351331e-0142-7ac5-e053-2995a90a844cac026e73-463a-67b7-e053-2a95a90a7f9d2021-12-16WarningsExact identifier
spl id: d351331e-0142-7ac5-e053-2995a90a844c
spl set id: ac026e73-463a-67b7-e053-2a95a90a7f9d

Reported adverse events (FAERS/openFDA)#

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