NDC 76547-070 Palm-aid

Hand Sanitizer

NDC Product Code 76547-070

NDC 76547-070-11

Package Description: 50 mL in 1 BOTTLE

NDC 76547-070-13

Package Description: 120 mL in 1 BOTTLE

NDC 76547-070-30

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Palm-aid with NDC 76547-070 is a a human over the counter drug product labeled by Niko Cosmetics. The generic name of Palm-aid is hand sanitizer. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Niko Cosmetics

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.

Palm-aid 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 .7 mL/mL

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)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Niko Cosmetics
Labeler Code: 76547
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: 05-01-2020 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.

Palm-aid 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[S]

Ethyl alcohol - 70 % (v/v)

Purpose

Antiseptic

Use[S]

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

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water

Otc - Stop Use

Stop using and ask a doctor if irritation or rash occurs. These may be signs of serious conditions.

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.

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

Other Information

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

Inactive Ingredients

Aqua, Glycerin, Xanthan Gum

Palm-Aid Hand Sanitizer - 50 Ml

NIKO


TMMEDI-SPAPALM-AIDHand Sanitizer50 mL / 1.7 fl ozNDC: 76547-070-11Cruelty FreeRecycleMade in CanadaNIKO Cosmetics Inc.7-397 Humberline Dr., Toronto, ONCanada M9W 5T5 | www.niko.com1-888-388-6456NIKO


TMORGANICORGANIC SPAPALM-AIDHand Sanitizer50 mL / 1.7 fl ozNDC: 76547-070-11Cruelty FreeRecycleMade in CanadaNIKO Cosmetics Inc.7-397 Humberline Dr., Toronto, ONCanada M9W 5T5 | www.niko.com1-888-388-6456

Palm-Aid Hand Sanitizer - 120 Ml

NIKO


TMMEDI-SPAPALM-AIDHand Sanitizer120 mL / 4 fl ozNDC: 76547-070-13Cruelty FreeRecycleMade in CanadaNIKO Cosmetics Inc.7-397 Humberline Dr., Toronto, ONCanada M9W 5T5 | www.niko.com1-888-388-6456NIKO


TMORGANICORGANIC SPAPALM-AIDHand Sanitizer120 mL / 4 fl ozNDC: 76547-070-13Cruelty FreeRecycleMade in CanadaNIKO Cosmetics Inc.7-397 Humberline Dr., Toronto, ONCanada M9W 5T5 | www.niko.com1-888-388-6456

Palm-Aid Hand Sanitizer - 473 Ml

NIKO


TMMEDI-SPAPALM-AIDHand Sanitizer473 mL / 16 fl ozNDC: 76547-070-30Cruelty FreeRecycleMade in CanadaNIKO Cosmetics Inc.7-397 Humberline Dr., Toronto, ONCanada M9W 5T5 | www.niko.com1-888-388-6456NIKO


TMORGANICORGANIC SPAPALM-AIDHand Sanitizer473 mL / 16 fl ozNDC: 76547-070-30Cruelty FreeRecycleMade in CanadaNIKO Cosmetics Inc.7-397 Humberline Dr., Toronto, ONCanada M9W 5T5 | www.niko.com1-888-388-6456

* Please review the disclaimer below.