NDC 59555-200 I.c. Ivy Block

Zinc Acetate

NDC Product Code 59555-200

NDC CODE: 59555-200

Proprietary Name: I.c. Ivy Block What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Zinc Acetate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used after other medications to treat a certain liver disease (Wilson's disease). This inherited disease causes the liver to hold onto too much copper, resulting in liver damage and other serious problems. This medication causes the intestines to make more of a certain substance (a protein) that prevents the body from absorbing too much copper from food, thereby preventing further damage.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

NDC 59555-200-01

Package Description: 5 mL in 1 PACKET

NDC 59555-200-03

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 59555-200-04

Package Description: 59 mL in 1 BOTTLE, DISPENSING

NDC 59555-200-07

Package Description: 118 mL in 1 BOTTLE, DISPENSING

NDC 59555-200-08

Package Description: 236 mL in 1 BOTTLE, DISPENSING

NDC 59555-200-10

Package Description: 946 mL in 1 BOTTLE, PUMP

NDC 59555-200-11

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC 59555-200-16

Package Description: 4 mL in 1 PACKET

NDC Product Information

I.c. Ivy Block with NDC 59555-200 is a a human over the counter drug product labeled by R & R Lotion, Inc. The generic name of I.c. Ivy Block is zinc acetate. The product's dosage form is lotion and is administered via topical form.

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.

I.c. Ivy Block 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.

  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • QUATERNIUM-90 (UNII: BE5VYX4VP8)
  • BENTONITE (UNII: A3N5ZCN45C)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAURETH-7 (UNII: Z95S6G8201)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: R & R Lotion, Inc
Labeler Code: 59555
FDA Application Number: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 09-21-2021 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.

I.c. Ivy Block 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

Drug Facts

Active Ingredients

Zinc Acetate 0.1%

Purpose

Skin Protectant

Uses

Poison Ivy, Oak, Sumac Protectant

Warnings

  • For external use only - When using this productdo not get into eyesIf contact occurs, rinse eyes thoroughly with waterStop use and ask a doctor if condition worsensSymptoms last more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Shake well before useApply 15 minutes before exposureApply generously to dry, exposed skinAllow to dryApply every 4 hours for continued protection or sooner if neededAfter possible exposure with skin irritants, remove using IC Ivy CleanserChildren under 2 year - ask a doctor.

Other Information

Protect from excessive heat (48°C/120°F)

Inactive Ingredients

Di Water, Cyclopentasiloxane (and) Quaternium - 90 Bentonite (and) Trifluoromethyl C1-4 Alkyl Dimethicone (and) Propylene Carbonate, Bentonite, Dimethicone, Polyacrylamide (and) c13-14 Isoparaffin (and) Laureth-7, Glycerin, Magnesium Aluminum Silicate, Phenoxyethanol (and) Ethylhexlglycerin, PVP, Aloe Barbadensis Leaf Juice, Disodium EDTA, Hamamelis Virginiana (Witch Hazel) Water (and) Phenoxyethanol, Citric Acid

* Please review the disclaimer below.