NDC 65616-008 Sterillium Rub Fragrance Free


NDC Product Code 65616-008

NDC 65616-008-06

Package Description: 1000 mL in 1 BOTTLE, PUMP

NDC 65616-008-08

Package Description: 50 mL in 1 BOTTLE, SPRAY

NDC Product Information

Sterillium Rub Fragrance Free with NDC 65616-008 is a a human over the counter drug product labeled by Bode Chemie Gmbh. The generic name of Sterillium Rub Fragrance Free is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Bode Chemie Gmbh

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.

Sterillium Rub Fragrance Free 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 89.5 mL/100mL

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)

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: Bode Chemie Gmbh
Labeler Code: 65616
FDA Application Number: part333E 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: 07-31-2019 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: 12-31-2020 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.

Sterillium Rub Fragrance Free 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 85% w/w




  • Surgical hand antisepticsignificantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care


For external use only.Flammable, keep away from fire or flame.

Otc - Do Not Use

Do not use in or near the eyes or on mucous membranes.

Otc - When Using

When using this product and contact with the eyes occurs, flush immediately with water.

Otc - Stop Use

  • Stop use and ask a doctor ifirritation and redness developcondition persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.


  • Apply to clean, dry handsfor the first use of the day, use a nail pickdispense approx. 2 mL into hand, dip fingers of opposite hand into palm, working product under nails and into cuticlesrepeat procedure with other handwith hands still moist spread around the hand and lower 1/3 of the forearmreapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spacesfollowing application, rub hands until dryhands should remain moist for entire application time, approx. 1.5 minutes.

Inactive Ingredients

Water, Isopropyl Alcohol, Myristyl Alcohol, Glycerin

* Please review the disclaimer below.