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| Product NDC Code | 70722-203 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Aching head rub |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1811578 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | Little Moon Essentials | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts
Active Ingredients Camphor 3.09% Menthol 2.55%
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 Organic sesame oil (Sesamum Indicum) Organic Olive oil (Olea Europaea) Organic Ginger Powder( Zingiber officinales) Orgnic Castor oil (Ricinus Communis) Beeswax (Cera Alba) Wintergreen oil (Gaultheria Procumbens) Marjoram (Thymus Mastichina) Cinnamon oil (Cinnamomum Zeynalicum) Lavender oil (Lavandula Angustifolia) Eucalytus globulus Clary sage (Salvia Sclarea) Rosemary oil(Rosmarinus Officinalis) Basil oil (Ocimum basilicum) Peppermint oil (Mentha Piperita)
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 area until thoroughly absorbed into daily 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 sprains bruises
Spl product data elements
Usually a list of ingredients in a drug product.Aching Head Rub Camphor, menthol METHYL SALICYLATE GINGER OIL CASTOR OIL YELLOW WAX SWEET MARJORAM OIL CINNAMON OIL LAVENDER OIL EUCALYPTUS GLOBULUS LEAF CLARY SAGE ROSEMARY OIL BASIL OIL PEPPERMINT OIL MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM SESAME OIL CAMPHOR (NATURAL) CAMPHOR (NATURAL) OLIVE OIL
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- 14g Container 0.5oz Aching Head Rub Botton LME_Point5oz_ Salve_AchingHeadRub
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 Poison Control Center rigt 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 if 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 , sweling or blistering where the product was applied
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.Warning For external use only When using this product use only as directed read and follow a directions and warnings on this label Rare cases of serius 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 apply to wounds or damaged skin, broken or irritated skin A trasient burning sensation may occur upon application but generaly disappears 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