NDC 59555-230 Ic Ivy Relief

Diphenhydramine Hydrochloride And Zinc Acetate

NDC Product Code 59555-230

NDC 59555-230-04

Package Description: 59 mL in 1 BOTTLE, DISPENSING

NDC 59555-230-07

Package Description: 118 mL in 1 BOTTLE, DISPENSING

NDC 59555-230-18

Package Description: 1 mL in 1 PACKET

NDC 59555-230-19

Package Description: 20 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Ic Ivy Relief with NDC 59555-230 is a a human over the counter drug product labeled by R & R Lotion, Inc. The generic name of Ic Ivy Relief is diphenhydramine hydrochloride and zinc acetate. The product's dosage form is liquid and is administered via topical form.

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.

Ic Ivy Relief 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.

  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE K30 (UNII: U725QWY32X)

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: part348 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: 09-01-2021 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.

Ic Ivy Relief 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

Otc - Purpose

Active IngredientsPurposeDiphenhydramine HCL 2%Topical AnalgesicZinc Acetate 0.1%Skin Protectant

Uses

  • Temporary relieves pain and itching associated with: Insect BitesMinor BurnsMinor CutsSunburnMinor Skin IrritationsScrapesDries oozing and weeping of Poison Ivy, Poison Oak, and Poison SumacRashes due to Poison Ivy, Poison Oak, and Poison Sumac.

Warnings

  • For external use only. Do not use on large areas of the bodywith any other product containing diphenhydramine, even one taken by mouth.

Otc - Ask Doctor

  • Ask doctor before use on chicken poxon measles

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

  • Stop use and ask doctor if conditions worsen, or do not improve within 7 dayssymptoms persist for 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 children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Do not use more than directedHold stick straight down over infected areapress tip of stick repeatedly on affect skin area until liquid flows, then dab sparinglyadults and children 2 years of age and older: apply to affected area not more then 3 to 4 times dailychildren under 2 years of age: ask a doctor

Other Information

Protect from excessive heat (40ºC/104ºF)

Inactive Ingredients

Propylene Glycol, Xanthan Gum, DI Water, PVP K-30

* Please review the disclaimer below.