NDC 71056-120 Re-charge Ph

Panthenol

NDC Product Code 71056-120

NDC 71056-120-01

Package Description: 1 BOTTLE, PUMP in 1 BOX > 1 mL in 1 BOTTLE, PUMP

NDC Product Information

Re-charge Ph with NDC 71056-120 is a a human over the counter drug product labeled by Goldeneye Permanent System Gmbh. The generic name of Re-charge Ph is panthenol. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Goldeneye Permanent System Gmbh

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Re-charge Ph 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.

  • PANTHENOL 15 mg/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.

  • INOSITOL (UNII: 4L6452S749)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • UREA (UNII: 8W8T17847W)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • MACLURA COCHINCHINENSIS WHOLE (UNII: X083FY34PH)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • GLYCINE (UNII: TE7660XO1C)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • BETAINE (UNII: 3SCV180C9W)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • 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: Goldeneye Permanent System Gmbh
Labeler Code: 71056
Marketing Category: UNAPPROVED DRUG OTHER - 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: 02-01-2020 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.

Re-charge Ph Product Label Images

Re-charge Ph 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

Directions

Apply one full pump of the lotion evenly onto face avoiding eye areas.

Otc - Active Ingredient

Panthenol (1.5%)............skin protectant

Otc - Ask Doctor

If irritation persists after application then stop use immiediatly and see a doctor.

Otc - Keep Out Of Reach Of Children

If accidently ingested then see a doctor immediately. If it gets into eyes rinse out and see a doctor.

Otc - Purpose

To soothe irritated and inflamed skin. Control excessive oil secretion. To protect and replenish skin barrier while providing ample long lasting hydration to the skin.

Otc - Questions

For comments and questions call 201 917 5858.

Warnings

Stop use if redness or irritation is persistant. See a doctor if condition worsens after you have stopped using the product.

Indications & Usage

Use on clean and dry skin, morning and night after using a tonic.

Inactive Ingredient

AQUA (WATER), GLYCERIN, BETAINE, PROPANEDIOL, PHENOXYETHANOL, HYDROXYETHYLCELLULOSE,

ALLANTOIN, SODIUM LACTATE, SODIUM PCA, SODIUM HYALURONATE, BENZOIC ACID, DEHYDROACETIC ACID, SODIUM PHYTATE,

MACLURA COCHINCHINENSIS LEAF PRENYLFLAVONOIDS, SODIUM HYDROXIDE, INOSITOL, LACTIC ACID, NIACINAMIDE, FRUCTOSE,

GLYCINE, UREA, SODIUM BENZOATE, ALCOHOL

* Please review the disclaimer below.