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Product NDC Code | 72839-087 | ||||
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Drug Name | Dch pain relief roll-on |
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Type | Brand | ||||
Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1010077 | ||||
Application Number | part348 | ||||
Labeler Name | Derma Care Research Labs, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Lidocaine HCl 4%
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.For the temporary relief of pain and itching.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, SD Alcohol 40, Steareth-21, 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.Adults and children 12 years and older: apply to the affected area, not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.DCH Pain Relief Roll-On Lidocaine HCl 4% STEARETH-21 ETHYLHEXYLGLYCERIN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS GLYCERYL MONOSTEARATE CETETH-20 PHOSPHATE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) ALOE VERA LEAF AMINOMETHYLPROPANOL DIHEXADECYL PHOSPHATE EDETATE DISODIUM CAPRYLYL TRISILOXANE METHYLPARABEN CETOSTEARYL ALCOHOL WATER C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER DIMETHICONE 200 ALCOHOL
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.Carton
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.In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if the condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few 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