NDC 66738-101 Jack Black Performance Remedy Dragon Ice

Menthol

NDC Product Code 66738-101

NDC Code: 66738-101

Proprietary Name: Jack Black Performance Remedy Dragon Ice 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: Menthol 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.

NDC Code Structure

  • 66738 - Jack Black Llc
    • 66738-101 - Jack Black Performance Remedy Dragon Ice

NDC 66738-101-11

Package Description: 113 g in 1 TUBE

NDC Product Information

Jack Black Performance Remedy Dragon Ice with NDC 66738-101 is a a human over the counter drug product labeled by Jack Black Llc. The generic name of Jack Black Performance Remedy Dragon Ice is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Jack Black Llc

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.

Jack Black Performance Remedy Dragon Ice 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.

  • MENTHOL 2.2 g/100g

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)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • CURDLAN (UNII: 6930DL209R)
  • .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
  • BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CINNAMON BARK OIL (UNII: XE54U569EC)
  • LEMON OIL (UNII: I9GRO824LL)
  • CROTON LECHLERI RESIN (UNII: GGG6W25C63)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • GOLDENSEAL (UNII: ZW3Z11D0JV)
  • LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
  • LONICERA JAPONICA TOP (UNII: 60Q6UP226V)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • OREGANO LEAF OIL (UNII: 7D0CGR40U1)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • GINGER (UNII: C5529G5JPQ)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • THYMOL (UNII: 3J50XA376E)

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: Jack Black Llc
Labeler Code: 66738
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: 07-13-2019 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: 12-31-2020 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.

Jack Black Performance Remedy Dragon Ice Product Label Images

Jack Black Performance Remedy Dragon Ice 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 Ingredient

MENTHOL 2.2%

Purpose

TOPICAL ANALGESIC

Indications

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH STRAINS, BRUISES, SPRAINS, SIMPLE BACKACHE, AND ARTHRITIS.

Warnings

  • FOR EXTERNAL USE ONLY.AVOID CONTACT WITH EYES AND MUCOUS MEMBRANES.DO NOT USE ON SENSITIVE AREAS, FACE, OR EYE AREA.IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.DO NOT APPLY TO WOUNDS OR DAMAGED SKIN, OR IRRITATED AREAS.DO NOT BANDAGE TIGHTLY IN THE AREA WHERE PRODUCT IS APPLIED.DO NOT USE A HEATING PAD IN AREA WHERE PRODUCT IS APPLIED.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

ADULTS AND CHILDREN 2 YEARS OF AGE OR OLDER: APPLY TO AFFECTED AREAS NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER2 YEARS OF AGE CONSULT A DOCTOR. GENTLY MASSAGE INTO ACHY POINTS ON THE BODY. WASH HANDS AFTER USE WITH COOL WATER. PRODUCT WILL GRADUALLY ACTIVATE AND WARM TO PROVIDE LONG-LASTING RELIEF.

Inactive Ingredients

WATER, PROPANEDIOL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, DIMETHYL SULFONE, PEG-8 DIMETHICONE, MENTHYL LACTATE, ACTYLATES/C10-30 ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE*, ARNICA MONTANA FLOWER EXTRACT, BETA-GLUCAN, BISABOLOL, BOSWELLIA SERRATA EXTRACT, CARBOMER, CHLORPHENESIN, CINNAMOMUM ZEYLANICUM BARK OIL, CITRUS LIMON (LEMON) PEEL OIL, CROTON LECHLERI RESIN EXTRACT, DISODIUM EDTA, EPILOBUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, EUCALYPTUS GLOBULUS LEAF OIL, GLYCERIN, GLYCINE SOJA (SOYBEAN) SEED EXTRACT*, HYDRASTIS CANADENSIS (GOLDENSEAL) ROOT EXTRACT, LAVENDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT*, LAVENDULA ANGUSTIFOLIA (LAVENDER) OIL, LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, MENTHA PIPERITA (PEPPERMINT) OIL, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ORIGANUM VULGARE LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SODIUM HYDROXIDE, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TOCOPHEROL, THYMOL*CERTIFIED ORGANIC

Other Information

STORE IN COOL, DRY PLACE WITH CAP CLOSED TIGHTLY.

Questions?

1-877-766-3388

* Please review the disclaimer below.

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