NDC 78580-010 Rolhei 75 Percent Ethanol Wet Wipe

NDC Product Information

Rolhei 75 Percent Ethanol Wet Wipe with NDC 78580-010 is product labeled by Glory Co., Ltd.. The product's dosage form is and is administered via form.

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)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Labeler Information

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

Labeler Name: Glory Co., Ltd.
Labeler Code: 78580
Start Marketing Date: 06-01-2020 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Rolhei 75 Percent Ethanol Wet Wipe Product Label Images

Rolhei 75 Percent Ethanol Wet Wipe 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 75% v/v

Inactive Ingredients

Water, Cetylpyridinium chloride, Glycerin, Polysorbate, Caprylhydroxamic acid, Citric acid

Purpose

ANTISEPTIC

Warnings

For external use only. Flammable. Keep away from heat or flame--------------------------------------------------------------------------------------------------------Do not use• in children less than 2 months of age• on open skin wounds--------------------------------------------------------------------------------------------------------When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.--------------------------------------------------------------------------------------------------------Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children

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

Uses

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

Directions

■ Wet hands thoroughly with product and allow to dry without wiping■ Do not flush■ Children under 2 years ask a doctor before use

Other Information

■ Read the directions and warnings before use■ Store between 15-30℃(59-89℉)■ Avoid freezing and excessive heat above 40℃(104 ℉)

* Please review the disclaimer below.