NDC 54860-281 Nimbus9 Hand Sanitizer 3.78l 01

Alcohol

NDC Product Code 54860-281

NDC 54860-281-01

Package Description: 3217 g in 1 BOTTLE, PLASTIC

NDC Product Information

Nimbus9 Hand Sanitizer 3.78l 01 with NDC 54860-281 is a a human over the counter drug product labeled by Shenzhen Lantern Scicence Co Ltd. The generic name of Nimbus9 Hand Sanitizer 3.78l 01 is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Shenzhen Lantern Scicence Co Ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Nimbus9 Hand Sanitizer 3.78l 01 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.

  • ALCOHOL 71 g/100g

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.
  • 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: Shenzhen Lantern Scicence Co Ltd
Labeler Code: 54860
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: 05-27-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Nimbus9 Hand Sanitizer 3.78l 01 Product Label Images

Nimbus9 Hand Sanitizer 3.78l 01 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

Active Ingredient PurposeEthyl Alcohol 71%(w/w) Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

Dosage & Administration

Recommended for repeated use.use anywhere without water.

Warning

For external use only-hands.Flammable,keep away from heat and flame.

Warnings And Precautions

For external use only.Flammable, keep away from heat and flame.

Otc - Stop Use

Discontinue if skin becomes irritated and ask a doctor .

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poson control center immediately.

Inactive Ingredients

Water(Aqua),Glycerin,Propylene Glycol,Carbomer,Aminomethyl Propanol,Parfum.

Directions

Place enough product on hands to cover all surfaces,Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Otc - Do Not Use

When using this productkeep out of eyes. In case of contact with eyes, flush thoroughly with water.Do not inhale or ingest.Avoid contact with broken skin.

Other Information

Do not store above 105F.May discolor some fabrics. Harmful to wood finishes and plastics.

Store between 15-30 C(59-86F)Avoid freezing and excessive heat above 40C(104F)

Keep Out Of Reach Of Children

If swallowed,get medical help or contact a Poison Control Center right away.

Do Not Use

In children less than 2 months of age.on open skin wounds.

Stop Use And Ask A Doctor

If irritation or rash occurs,these maybe signs of a serious condition.

* Please review the disclaimer below.