NDC 54622-121 Enmotion Foam High Frequency Use

Ethyl Alcohol

NDC Product Code 54622-121

NDC 54622-121-01

Package Description: 2 BOTTLE in 1 BOX > 1000 mL in 1 BOTTLE

NDC Product Information

Enmotion Foam High Frequency Use with NDC 54622-121 is a a human over the counter drug product labeled by Georgia Pacific Consumer Products. The generic name of Enmotion Foam High Frequency Use is ethyl alcohol. The product's dosage form is solution and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 616805.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Enmotion Foam High Frequency Use Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
  • EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • .BETA.-BISABOLOL (UNII: LP618AV2EA)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ACETYL HEXAPEPTIDE-49 (UNII: 4055X1S509)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Georgia Pacific Consumer Products
Labeler Code: 54622
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-10-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Enmotion Foam High Frequency Use Product Label Images

Enmotion Foam High Frequency Use Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

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

Warnings

  • FLAMMABLE, keep away from fire or flameFor external use only

Otc - When Using

When using this product do not use in or near eyes.

Otc - Stop Use

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

Keep out of reach of children.If swallowed, seek immediate medical attention or call a poison control center.

Directions

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

Inactive Ingredients

Water, Isopropyl Alcohol*, PEG-12 Dimethicone, Glycerin, Hydrolyzed Jojoba Esters, Caprylic/Capric Triglyceride, Panthenol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Euterpe Oleracea Fruit Extract, Butylene Glycol, Bisabolol, Phenoxyethanol, Citric Acid, Sodium Benzoate, Potassium Sorbate, Acetyl Hexapeptide-49*may contain this ingredient

Rear Label Text

EnMotionHigh Frequency UseFoam Hand SanitizerFragrance Free SKU 42336Manufactured forGeorgia-Pacific Consumer Products. Atlanta, GA 30303Quesitons? Call 1-866-HELLOGP (435-5647)
or visit us online at www.gppro.com(c) 2021 GP PRO. All rights reserved.alcohol permit SDS-KY-150025000008656/000/02

* Please review the disclaimer below.