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Sanar - arnica roll on - Medication Information

Product NDC Code 73386-005
Drug Name

Sanar - arnica roll on

Type Brand
Active Ingredients
Camphor (synthetic) 1 g/100ml
Route TOPICAL
Dosage Form GEL
Application Number part348
Labeler Name SANVALL ENTERPRISES, INC
Packages
Package NDC Code Description
73386-005-03 88.5 ml in 1 bottle (73386-005-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Camphor 1%

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.
Directions: Adults and Children over 12 years: Apply generously to affected area. Massage until thoroughly absorbed.Repeat as necessary, but not more than 3 times daily. Children under 12 years: Consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Aqua, Ceteareth-25, Arnica Montana Flower Extract, Alcohol Denat, Menthol, Glycerin, Triethanolamine, Methyl Salicylate, Carbomer, Eucalyptus Globulus Leaf Oil, Disodium EDTA, Tocopheryl Acetate, Capsicum Annuum Fruit Extract, Methylchloroisothiazolinone, Methylisothiazolinone.

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.
Uses: Aid for temporary local relief of minor pain in muscles or joints.

Purpose

Information about the drug product’s indications for use.
Pain Relieving

Spl product data elements

Usually a list of ingredients in a drug product.
SANAR - ARNICA ROLL ON Camphor CAPSICUM ALCOHOL METHYL SALICYLATE CARBOMER 940 MENTHOL GLYCERIN DISODIUM EDTA-COPPER METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE ARNICA MONTANA FLOWER EUCALYPTUS GLOBULUS LEAF CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) WATER CETEARETH-25 TROLAMINE .ALPHA.-TOCOPHEROL ACETATE

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.
3oz

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Use on wounds or damaged skin • bandage tightly.

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

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Store tightly closed in a dry place at controlled room temperature between 59°-77° F (15°-25° C). • Processed under the highest standards of quality assurance and Good Manufacturing Practices

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 consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again.

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.
For external use only. Avoid contact with eyes.

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