MedPath

enMotion Foam

enMotion 708.000/708AA Foam hand sanitizer with moisturizers

Approved
Approval ID

6f0b8537-fe1f-4265-ab1a-e869d16fb60e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

Georgia-Pacific Consumer Products LP

DUNS: 806142217

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 Code54622-708
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (12)

ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEG-12 DIMETHICONEInactive
Code: ZEL54N6W95
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)Inactive
Code: UDR641JW8W
Classification: IACT
GLYCERYL CAPRYLATE/CAPRATEInactive
Code: G7515SW10N
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ALCOHOLActive
Quantity: 70 mg in 1 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

principal display panel

Foam Hand Sanitizer with Moisturizers

G-100520-PRDRevA16

1000 mL (33.8 FL OZ)

image description

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

Uses

  • To decrease bacteria on skin that could cause disease
  • Recommended for repeated use

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/12/2025

ADVERSE REACTION

Manufactured for Georgia-Pacific Consumer Products LP. Atlanta, GA 30303

Questions? Call 1-866-HELLOGP (435-5647)

or visit us online at www.gppro.com

©2016 Georgia Pacific Consumer Products LP. All rights reserved.

alcohol permit SDS-MO-15036, DSP-MO-28, DSP-MO-34

42334-1 PRDRevA16

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/12/2025

Directions

Wet hands thoroughly with product and allow to dry without wiping.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

Inactive ingredients

Water, Isopropyl Alcohol, PEG-12 Dimethicone, Glycerin, Hydrolyzed Jojoba Esters, Caprylic/Capric Triglyceride, Panthenol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, FD&C Blue #1, FD&C Yellow #5.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/12/2025

Claims

enMotion ®

Foam Hand Sanitizer

with Moisturizers

Fragrance Free • SKU 42334

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/12/2025

Active ingredient

Ethyl Alcohol 70% v/v

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

Warnings

***FLAMMABLE, keep away from fire or flame** *For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/12/2025

When using this product

do not use in or near eyes.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/12/2025

Stop use and ask a doctor

if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/12/2025

Keep out of reach of children.

If swallowed, seek immediate medical attention or call a poison control center.

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enMotion Foam - FDA Drug Approval Details