NDC 55550-250 Hand Sanitizer Handy Helper Wipes

Alcohol

NDC Product Code 55550-250

NDC 55550-250-78

Package Description: 100 PACKET in 1 BOX > 3 mL in 1 PACKET

NDC Product Information

Hand Sanitizer Handy Helper Wipes with NDC 55550-250 is a a human over the counter drug product labeled by Total Resources International. The generic name of Hand Sanitizer Handy Helper Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Total Resources International

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Hand Sanitizer Handy Helper Wipes 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 65 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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

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: Total Resources International
Labeler Code: 55550
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: 05-01-2020 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.

Hand Sanitizer Handy Helper Wipes Product Label Images

Hand Sanitizer Handy Helper Wipes 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 Ingredeint

Ethyl Alcohol 65% v/v

Purpose

Antiseptic

Uses

  • For hand sanitizing to decrease bacteria on skin.recommended for repeated use

Warnings

  • For external use onlyFlammable, keep away from flame or fireWhen using this product avoid contact with eyes. If in eyes, flush thoroughly with waterDiscontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours

Keep Out Of Reach Of Children

If swallowed get medical help or contact a poison control center right away

Directions

  • Open packetremove and unfold wipewet hands thoroughly with product and let hands drythrow used wipe in trash, do not flush

Inactive Ingredeints

Water, Aloe barbadensis leaf juice, Tocopheryl Acetate

Label

HAND

SANITIZER
Handy Helper wipesKills 99.99% of Germs

Antimicrobial • Cleans • Sanitizes • Gentle

Effective • Vitamin E • Aloe Vera
•Ethyl Alcohol • Antiseptic100PCSFamily Owned and Operated Providing three decades of First Aid & Safety SolutionsFor every kit purchased, YOU GIVEBACK to bring hope, help, andhealing one community at a time.#EveryKitCaresFEATURES:• Antimicrobial• Kills 99.99% of germs• Dries in seconds• Infused with aloe vera & vitamin E• Extra soft & gently moisturizes• Refreshes handsFOR BEST RESULTS:• Discard after single use• Dispose of used wipes in trash• Do not flush used wipes• Store at room temperaturePERFECT FOR:• Home• School• Office• Nuseries• Restaurants• Cafeterias• Caterers• TravelMade in USA

* Please review the disclaimer below.