NDC 82171-003 Ritual Tattoo Reveal Foam

Lidocaine, Tetracaine, Witch Hazel

NDC Product Code 82171-003

NDC 82171-003-60

Package Description: 60 mL in 1 BOTTLE

NDC Product Information

Ritual Tattoo Reveal Foam with NDC 82171-003 is a a human over the counter drug product labeled by Mk Laboratory. The generic name of Ritual Tattoo Reveal Foam is lidocaine, tetracaine, witch hazel. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2569968.

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.

Ritual Tattoo Reveal Foam 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)
  • PALM KERNEL OIL (UNII: B0S90M0233)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • WATER (UNII: 059QF0KO0R)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • JOJOBA OIL (UNII: 724GKU717M)

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: Mk Laboratory
Labeler Code: 82171
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.

Ritual Tattoo Reveal Foam Product Label Images

Ritual Tattoo Reveal Foam 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 Ingredients

Lidocaine 2% w/v. Purpose: Topical analgesicTetracaine 1% w/v. Purpose: Topical analgesicWitch Hazel 30% w/v. Purpose: Astringent

Purpose

Lidocaine 2% w/v. Purpose: Topical analgesicTetracaine 1% w/v. Purpose: Topical analgesicWitch Hazel 30% w/v. Purpose: Astringent

Uses

  • For temporary relief of pain during tattoo and piercing procedures.Reduce sensitivity, inflammation, and redness during tattoo and piercing aftercare

Warnings

  • For external use only.Check with client for history of allergic reactions to topical analgesics.

Otc - Do Not Use

DO NOT USE more than 30 mL in a 6 hour period.

Otc - When Using

  • Avoid contact with eyes. In case of eye contact, flush eyes with water.

Otc - Stop Use

  • Stop use and contact doctor if skin irritations occur. If irritation, rinse thoroughly with water.If swallowed, get medical help or contact Poison Control Center. 1-800-222-1222

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Directions

  • Pump foam generously, spread over tattoo or piercing and let sit 10-30 seconds before wiping with damp paper towel.For use during breaks and on completed tattoos and piercing. Also great for aftercare uses.

Inactive Ingredients

Cannabis Sativa Seed Oil (Hempseed Oil), Citric Acid, Coconut Oil, Glycerin, Hydroxide Pellets, Jojoba Oil, Olea Europaea Fruit Oil, Palm Kernel Flakes, Potassium, Tocopheryl Acetate (Vitamin E Oil), Water

* Please review the disclaimer below.