MedPath

Hand Sanitizing Wipes

Germ-X 100.001/100AA Hand Sanitizing Wipes

Approved
Approval ID

ca7c6243-dc7f-40c4-8b51-ec9a7c1f14f5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

UpLift Brands, LLC

DUNS: 119091527

Products 1

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

Ethyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83986-100
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
ALCOHOLActive
Quantity: 67 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/26/2025

Principal display panel

TSA CARRY-ON READY

germ-X ®

Since 1997

Antibacterial

Ultra Soft

Hand Sanitizing Wipes

With Vitamin E

DO NOT FLUSH

100 Total Wipes

6 in x 5 in (15.2 cm x 12.7 cm)

Individually Wrapped Wipes

Office · School · On-The-Go

USE EVERYWHERE FOR HAND SANITIZING ON THE GO!

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/26/2025

Use

to decrease bacteria on the skin

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/26/2025

Adverse reaction

Distributed by: UpLift Brands, LLC

St. Louis MO 63114

1-866 MY GERMX

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/26/2025

Side panel claims

TSA CARRY-ON READY

germ-X ®

SINCE 1997

ANTIBACTERIAL

Hand Sanitizing Wipes

KILLS 99.99% OF GERMS*

100 INDIVIDUALLY WRAPPED WIPES

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/26/2025

Active ingredient

Ethyl Alcohol 67% v/v

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/26/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/26/2025

Warnings

For external use only: hands

Flammable, keep away from fire or flame.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/26/2025

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/26/2025

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/26/2025

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/26/2025

Directions

  • wipe hands thoroughly with product and allow to dry
  • for children under 6, use only under adult supervison
  • not recommended for infants

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/26/2025

Inactive ingredients

aloe barbadensis leaf juice, tocopheryl acetate, water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/26/2025

Questions?

1-866 MY GERMX 1-866-694-3769

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