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| Product NDC Code | 59088-310 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dermacinrx penetral cream |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 198555 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | PureTek Corporation | ||||||
| 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.Active ingredient Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%) Purpose Topical Analgesic
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 Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock. Before using on children under 18 years of age, consult a physician. Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction. Gently massage into the skin until fully absorbed. Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Euterpe Oleracea (Acai) Fruit Oil, Glycerin,Hydrated Silica, Hydrolyzed Corn Starch, Hydrolyzed Corn Starch Octenylsuccinate, Lauryl Laurate, Linum Usitatissimum (Linseed) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine, Zea Mays (Corn) Starch.
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 for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.DermacinRx Penetral Cream Capsaicin AMYLOPECTIN, UNSPECIFIED SOURCE STARCH, CORN HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE LAURYL LAURATE TROLAMINE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A WATER ALOE VERA LEAF ARNICA MONTANA FLOWER ALCOHOL ETHYL MENTHANE CARBOXAMIDE ACAI OIL HYDRATED SILICA GLYCERIN CAPSICUM OLEORESIN CAPSICUM OLEORESIN CAPSAICIN CORN SYRUP PEPPERMINT OIL MENTHYL LACTATE, (-)- METHYL DIISOPROPYL PROPIONAMIDE PHENOXYETHANOL PPG-2 HYDROXYETHYL COCAMIDE ROSEMARY OIL CARBOMER INTERPOLYMER TYPE A (55000 CPS) OCTENYLSUCCINIC ANHYDRIDE LINSEED 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.DermacinRx ® Penetral™ Cream Label Label
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.This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.
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 and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll-free 1-877-921-7873 or visit us at www.dermacinrx.com
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.Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.
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 do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.
Storage and handling
Information about safe storage and handling of the drug product.Other information WARNING: FLAMMABLE PRODUCT Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.
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 This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns. When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention 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