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Dream cream - Medication Information

Product NDC Code 70722-232
Drug Name

Dream cream

Type Brand
Active Ingredients
Camphor (natural) .45 g/100g
Menthol, unspecified form 5 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1812330
Application Number part348
Labeler Name Little Moon Essentials
Packages
Package NDC Code Description
70722-232-04 113 g in 1 container (70722-232-04)
70722-232-02 56.7 g in 1 container (70722-232-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug Facts Active Ingredients Camphor 0.45% Menthol 5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Purpose Topical Analgesic

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water (aqua) Organic safflower oil (cathamus tinctorius) Beeswax (cera alba) Cetearyl olivate Arnica oil (arnica montana) Castor oil (ricinus communis) Cetearyl alcohol Wintergreen oil (gaultheria procumbens) Xanthan gum Cinnamom oil (Cinnamomum zeylanicum) Lavender oil (lavendula angustifolia) Cyprus oil ( cupressus sempervirens) Eucalyptus blue mallee oil Marjoram (thymus mastichina) Rosemary oil (rosmarinus officinalis) Juniper oil (juniperus communis) magnesium aluminum silicate Immortelle 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 sorbate Sodium benzoate

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Uses Temporarily relieves minor pain associated with Simple backache Muscle strains Strains Bruises

Spl product data elements

Usually a list of ingredients in a drug product.
Dream Cream Camphor, Menthol CETEARYL OLIVATE SWEET MARJORAM STYRAX BENZOIN RESIN POTASSIUM SORBATE GINGER CAMPHOR (NATURAL) CAMPHOR (NATURAL) WATER SAFFLOWER OIL YELLOW WAX ARNICA MONTANA CASTOR OIL CETOSTEARYL ALCOHOL METHYL SALICYLATE XANTHAN GUM CINNAMON OIL LAVENDER OIL CUPRESSUS SEMPERVIRENS LEAF OIL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM EUCALYPTUS POLYBRACTEA LEAF OIL ROSEMARY OIL JUNIPERUS OXYCEDRUS LEAF OIL MAGNESIUM ALUMINUM SILICATE PSEUDOGNAPHALIUM LUTEOALBUM WHOLE CLARY SAGE TEA TREE OIL PEPPERMINT OIL BASIL OIL SODIUM BENZOATE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principle Display Panel 113g container 4 oz Dream Cream. 4 oz Vital Vapor Fold 2. 4 oz Vital Vapor Fold 1.

Instructions for use

Information about safe handling and use of the drug product.
Other information Store at 68-77ºF (20-25ºC) ​Protect from excessive moisture

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor ​Condition worsens Redness is present Irritation develops Symptoms persist for more than 7 days or clear up and occur again within a few days You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast feeding ​ Ask a health professional before use

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 use Avoid contact with eyes and mucous membranes Do not aply to wounds or damaged, broken irritated skin A trasient burning sensation may occur upon application but generally dissapears in several days

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API