NDC 76555-007 Evelinecharles Pure Purifying Hand Cream Max

Alcohol

NDC Product Code 76555-007

NDC 76555-007-01

Package Description: 60 g in 1 TUBE

NDC Product Information

Evelinecharles Pure Purifying Hand Cream Max with NDC 76555-007 is a a human over the counter drug product labeled by Ec Labs Inc.. The generic name of Evelinecharles Pure Purifying Hand Cream Max is alcohol. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Evelinecharles Pure Purifying Hand Cream Max 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.


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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG/PPG-18/12 DIMETHICONE (UNII: 2AY8NFX9E4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
  • 3-CARENE (UNII: H2M15SNR6N)
  • DIHYDROMYRCENOL (MIXED ISOMERS) (UNII: 7E6BIK8N98)
  • ETHYL LINALOOL (UNII: SF2JS9GF5T)
  • CEDRAMBER (UNII: 84S7T555CV)
  • CYMENE (UNII: 830CI19HHD)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
  • .BETA.-PINENE (UNII: 4MS8VHZ1HJ)
  • GERANIOL (UNII: L837108USY)
  • METHYL IONONES (UNII: EL78BGX1LO)
  • .ALPHA.-PINENE (UNII: JPF3YI7O34)
  • PENTADECALACTONE (UNII: OK17S3S98K)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • DIHYDRO PENTAMETHYLINDANONE (UNII: BZR4438MY4)
  • COUMARIN (UNII: A4VZ22K1WT)
  • LINALYL ACETATE (UNII: 5K47SSQ51G)
  • BOURGEONAL (UNII: H3XVS6E70V)
  • 2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • .GAMMA.-TERPINENE (UNII: 4YGF4PQP49)
  • METHYL 3-METHYLORSELLINATE (UNII: 12YH9T04QE)
  • ALLYL CYCLOHEXANEBUTYRATE (UNII: 9JIF47RD7B)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • 3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
  • AMBREIN (UNII: 1N9JB373FJ)
  • CYCLOHEXANEPROPANOL, 2,2,6-TRIMETHYL-.ALPHA.-PROPYL- (UNII: CLV4EM4325)

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: Ec Labs Inc.
Labeler Code: 76555
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: 10-28-2021 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: 12-31-2022 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 - NO 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.

Evelinecharles Pure Purifying Hand Cream Max Product Label Images

Evelinecharles Pure Purifying Hand Cream Max 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

Other

  • This is a hand sanitizer manufactured according to the
  • Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
  • The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.Glycerol (1.45% v/v).Hydrogen peroxide (0.125% v/v).Sterile distilled water or boiled cold water.The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

Alcohol 63% w/w. Purpose: Antimicrobial

Purpose

Antimicrobial, Purifying Hand Cream

Use

Eliminates bacteria and germs.

Warnings

Flammable. Keep away from open flame and sources of heat. This product is intended for external use only.

Do Not Use

Do not use in children less than 2 months of age and on open skin wounds.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use if irritation or redness develops and consult a doctor.

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

Apply a small amount to hands and spread evenly.Rub thoroughly into hands for at least 30 seconds.

Other Information

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

Inactive Ingredients

Glycerin, purified water USP

* Please review the disclaimer below.