NDC 70722-208 Ass Kisser

Camphor, Menthol

NDC Product Code 70722-208

NDC 70722-208-03

Package Description: 85.05 g in 1 CONTAINER

NDC 70722-208-05

Package Description: 14 g in 1 CONTAINER

NDC Product Information

Ass Kisser with NDC 70722-208 is a a human over the counter drug product labeled by Little Moon Essentials. The generic name of Ass Kisser is camphor, menthol. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1811858.

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.

Ass Kisser 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.

  • SESAME OIL (UNII: QX10HYY4QV)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • GINGER (UNII: C5529G5JPQ)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • GINGER OIL (UNII: SAS9Z1SVUK)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • RED PEPPER (UNII: 6M47G7C4SY)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CLARY SAGE (UNII: U3HSK5JC0Q)
  • GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
  • BASIL OIL (UNII: Z129UMU8LE)
  • SWEET MARJORAM (UNII: G9Z40ZYU6P)
  • CARDAMOM OIL (UNII: JM0KJ091HZ)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

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: Little Moon Essentials
Labeler Code: 70722
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: 09-29-2016 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 - 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.

Ass Kisser 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

Camphor 1.35%Menthol 2.86%

Purpose

Topical analgesic

Uses

  • Temporarily relieves minor pain associated withSimple backageMuscle strainsSprainsBruises

Warning

  • For external use only​When using this product​Use only as directed. Read and follow all directions and warnings on this label
  • Rare cases of serious burns have been reported with products of this typeDo not bandage tightly or apply local heat (such as heating pads) or medicated patches to the area of useAvoid contact with eyes and mucous membranesDo not apply to wounds or damaged, broken or irritated skinA trasient burning sensation may occur upon application but generally disappears in several days

Stop Use And Ask A Doctor

  • Condition worsensRedness is presentIrritation developsSymptoms persist for more than 7 days or clear up and occur again within a few daysYou experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding

Ask a health professional before use

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Adults and children over 12 years:Apply a thin layer to affected areaMassage into painful area until thoroughly absorbed into skinRepeat as necessary, but no more than 3 o 4 times daily, allowing a minimum of 2-3 hours between applicationsAFTER APPLYING, WASH HANDS WITH SOAP AND WATERChildren 12 years or younger: ask a doctor

Other Information

Store at 68-77ºF (20-25ºC)Protect from excessive moisture

Inactive Ingredients

Organic Sesame oil (Sesamum indicum)Organic Olive oil (Olea Europaea)Organic Cayenne powder (Capsicum frutescens)Organic Ginger powder ( Zingiber officinale)Organic Castor oil ( Ricinus communis)Beeswax (Cera alba)Wintergreen oil (Gaultheria procumbens)Rosemary oil ( Rosmarinus officinalis)Cinnamom oil (Cinnamomum zeylanicum)Lavender oil (Lavandula angustifolia)Clary sage (Salvia sclarea)Geranium oil (Pelargonium graveolens)Ginger oil (Zingiber officinale)Basil oil (Ocimum basilicum)Marjoram (Thymus mastichina)Cardamom oil (Elettaria cardamomum) Arnica (Arnica montana)st. john¹s wort (Hypericum perforatum)Calendula (Calendula officinalis)

* Please review the disclaimer below.