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Product NDC Code | 69842-420 | ||||
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Drug Name | Cvs calamine plus |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 1234532 | ||||
Application Number | M016 | ||||
Labeler Name | CVS Pharmacy | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Calamine 8%
Active Ingredient Pramoxine HCl 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 2 yrs. o f age and older . Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort. Children under 2 yrs. of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.
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.Use Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other minor skin irritations.
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.CVS Calamine Plus zinc oxide ALCOHOL CAMPHOR (SYNTHETIC) DIAZOLIDINYL UREA GLYCERIN HYPROMELLOSES METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE
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.PRINCIPAL DISPLAY PANEL Calamine Plus Itch Relief 6 FL OZ (177 mL) PRINCIPAL DISPLAY PANEL Calamine Plus Itch Relief 6 FL OZ (177 mL)
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.CVS Calamine Plus Drug Facts
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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store at room temperature 15 o – 30 o C (59 o – 85 o F)
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 last for more than 7 days or clear up and occur again within a few days.
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.
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 use only. Use only as directed. When using this product avoid contact with eyes. Stop use and ask a doctor if condition worsens symptoms last for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. In case of accidental ingestion, seek professional assistance 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