NDC 70722-232 Dream Cream

Camphor, Menthol

NDC Product Code 70722-232

NDC 70722-232-02

Package Description: 56.7 g in 1 CONTAINER

NDC 70722-232-04

Package Description: 113 g in 1 CONTAINER

NDC Product Information

Dream Cream with NDC 70722-232 is a a human over the counter drug product labeled by Little Moon Essentials. The generic name of Dream Cream 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: 1812330.

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.

Dream Cream 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.

  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SWEET MARJORAM (UNII: G9Z40ZYU6P)
  • STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • GINGER (UNII: C5529G5JPQ)
  • WATER (UNII: 059QF0KO0R)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)
  • EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • JUNIPERUS OXYCEDRUS LEAF OIL (UNII: YNW2QPG8YK)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • PSEUDOGNAPHALIUM LUTEOALBUM WHOLE (UNII: HR514FFZ7I)
  • CLARY SAGE (UNII: U3HSK5JC0Q)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • BASIL OIL (UNII: Z129UMU8LE)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: 10-04-2016 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.

Dream Cream 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 0.45%Menthol 5%

Purpose

Topical Analgesic

Uses

  • Temporarily relieves minor pain associated withSimple backacheMuscle strainsStrainsBruises

Warnings

  • For external using this product​Use only as irected
  • ​Read and follow all directions and warningson this label​Rare cases of serious burns have been reported with products of this type​Do 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 aply to wounds or damaged, broken irritated skinA trasient burning sensation may occur upon application but generally dissapears 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 area​Massage into painful aea until thoroughly absorbed into skin repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER​
  • ​​Children 12 years or younger: ask a doctor

Other Information

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

Inactive Ingredients

Water (aqua)Organic safflower oil (cathamus tinctorius)Beeswax (cera alba)Cetearyl olivateArnica oil (arnica montana)Castor oil (ricinus communis)Cetearyl alcoholWintergreen oil (gaultheria procumbens)Xanthan gumCinnamom oil (Cinnamomum zeylanicum)Lavender oil (lavendula angustifolia)Cyprus oil ( cupressus sempervirens)Eucalyptus blue mallee oilMarjoram (thymus mastichina)Rosemary oil (rosmarinus officinalis)Juniper oil (juniperus communis)magnesium aluminum silicateImmortelle oil (helichysum angustifolium)Clary sage oil (salvia sclarea)Tea tree oil (melaleuca alternifolia)Peppermint oil (mentha piperita)Basil oi (ocimum basilicum)ginger (zingiber officinale)Benzoin (styrax benzoin resin extract )Potassium sorbateSodium benzoate

* Please review the disclaimer below.