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Alcohol Wipes

Alcohol Wipes

Approved
Approval ID

0885cec4-deed-6aa8-e063-6294a90a9131

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Guangzhou Baihua Co., Ltd.

DUNS: 545015588

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code77665-104
Product Classification
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (4)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROGEN PEROXIDEInactive
Code: BBX060AN9V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLActive
Quantity: 75 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/18/2023

Package Label - Principal Display Panel

Alcohol WipesAlcohol Wipes(80pcs) 77665-104-01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/18/2023

Use

USES: HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/18/2023

Purpose

PURPOSE: ANTIMICROBIAL

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/18/2023

Active Ingredient(s)

ACTIVE INGREDIENT: Alcohol 75%

WARNINGS SECTION

LOINC: 34071-1Updated: 7/18/2023

Warnings

WARNINGS: FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

■ FOR EXTERNAL USE ONLY.

■ DO NOT USE IN OR NEAR THE EYES.

IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

■ STOP USE AND CONSULT WITH A PHYSICIAN IF IRRITATION DEVELOPS AND LASTS FOR MORE THAN 72 HOURS.

■ KEEP OUT OF REACH OF CHILDREN.

■ IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 7/18/2023

Do not use

■ DO NOT USE IN OR NEAR THE EYES.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/18/2023

IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

■ IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/18/2023

■ STOP USE AND CONSULT WITH A PHYSICIAN IF IRRITATION DEVELOPS AND LASTS FOR MORE THAN 72 HOURS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/18/2023

■ KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/18/2023

Directions

■ DISPENSING. LIFT THE FRONT LID. OPEN PROTECTIVE SEAL. PULL OUT WIPE, RESEAL, AND CLOSE THE LID.

■ USE. WIPE HANDS THOROUGHLY.

■ DISPOSAL. DO NOT FLUSH.

Directions of Use:
1. Open the lid and slowly peel back label.2. Pull out wipes as needed.
3. Reseal label to retain moisture.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/18/2023

Other information

STORAGE. STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/18/2023

Inactive ingredients

Glycerol, Hydrogen Peroxide, RO pure water

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Alcohol Wipes - FDA Drug Approval Details