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| Product NDC Code | 71917-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Cirlutone |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1991259 | ||||
| Application Number | part348 | ||||
| Labeler Name | Herbal Health LLC | ||||
| 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.Camphor 0.6%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Herbal Health L.L.C. Made in the U.S.A. www.cirlutone.com
Exp. Date: Lot No.: Manufactured by: Neutraderm, Inc. 20660 Nordhoff St. Chatsworth, CA. 91311 [email protected] www.cirlutone.com
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.Adults and children 2 years of age and older : apply to affected area not more than 3 to 4 times daily. Children under 2 yrs of age : consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Angelica anemala, Emulsifying Wax NF, Fragrance, Frankincense Oil, Isopropyl alcohol, Ligusticum wallichii, Magnolia liliflora, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sophora, Syzgium armaticum
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.For the temporary relief of pain associated with: sunburn minor cuts scrapes
Purpose
Information about the drug product’s indications for use.Camphor 0.6%...............Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Cirlutone Camphor CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) ANGELICA ANOMALA WHOLE WHITE WAX FRANKINCENSE OIL ISOPROPYL ALCOHOL LIGUSTICUM WALLICHII WHOLE MAGNOLIA LILIIFLORA WHOLE METHYLPARABEN MINERAL OIL PETROLATUM PROPYLPARABEN WATER SOPHORA FLAVESCENS WHOLE SYZYGIUM AROMATICUM WHOLE
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.CIRLUTONE Ointment Topical Analgesic Net Wt. 3.53oz/100g. CirlutoneCarton
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call 310-888-8878 Monday through Friday, 9am-5pm CST.
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 symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes or mucous membrane use only as directed Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Store in a cool & dry place Do not use if tamper evident seal is broken or missing
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. Flammable: keep away from fire or flame When using this product avoid contact with eyes or mucous membrane use only as directed Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.
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