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Neuromuscular cream - Medication Information

Product NDC Code 82984-0001
Drug Name

Neuromuscular cream

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine 4 g/100g
Route TOPICAL
Dosage Form CREAM
Application Number M017
Labeler Name BioClinical Science, LLC
Packages
Package NDC Code Description
82984-0001-2 59.2 g in 1 bottle, pump (82984-0001-2)
82984-0001-4 118.3 g in 1 bottle, pump (82984-0001-4)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
59.2 mL Active Ingredient Active Ingredient 118.3 mL Active Ingredient Section Active Ingredient

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.
59.2 mL Dosage and Administration Section Dire 118.3 mL Dosage and Administration Section Directions

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
59.2 mL Inactive Ingredient Section Inactive Ingredients 118.3 mL Inactive ingredient section Inactive ingredients

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.
59.2 mL Indications and Usage Section Use 118.3 mL Indications and Usage Section Use

Purpose

Information about the drug product’s indications for use.
59.2 mL Purpose Section Purpose 118.3 mL Purpose Section Purpose

Spl product data elements

Usually a list of ingredients in a drug product.
Neuromuscular Cream Lidocaine 4% SPEARMINT OIL HAMAMELIS VIRGINIANA LEAF WATER PHENOXYETHANOL GLYCERIN LIDOCAINE LIDOCAINE CAMPHOR OIL ROSEMARY OIL EAST INDIAN LEMONGRASS OIL MENTHOL CHAMAEMELUM NOBILE FLOWER OIL CITRONELLA OIL HELICHRYSUM ITALICUM FLOWER OIL JUNIPER BERRY OIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PEPPERMINT OIL CRYPTOCARYA AGATHOPHYLLA LEAF OIL EUCALYPTUS OIL ALOE CAPSICUM OLEORESIN PINE NEEDLE OIL (PINUS SYLVESTRIS) BASIL OIL TROLAMINE BLACK PEPPER OIL GRAPEFRUIT OIL OREGANO LEAF OIL CANNABIDIOL CINNAMON LEAF OIL TETRASODIUM GLUTAMATE DIACETATE CHAMOMILE FLOWER OIL ALCOHOL MEADOWFOAM SEED OIL GINGER 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.
59.2 mL Bottle 59.2 mL Bottle 118.3 mL Bottle 118.3 mL Bottle

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
59.2 mL Ask Doctor Section Ask a Doctor If 118.3 mL Ask Doctor Section Ask a doctor if

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.
59.2 mL Do Not Use Section Do Not Use 118.3 mL Do Not Use Section Do not use

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.
59.2 mL Keep out of reach of children section Keep out of reach of children 118.3 mL Keep out of reach of children section Keep out of reach of children

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
59.2 mL Questions Section Questions 118.3 mL Questions section Questions

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.
59.2 mL Stop Use Section Stop use and ask a doctor if 118.3 mL Stop Use Section Stop 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.
59.2 mL When Using Section When Using This Product 118.3 mL When Using Section When using this product

Pregnancy or breast feeding

Pregnancy or Breast feeding
59.2 mL Pregnancy or Breast Feeding Section If pregnant or breast-feeding 118.3 mL Pregnancy or Breast Feeding Section Pregnant or breast-feeding

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.
59.2 mL Warnings Section Warnings 118.3 mL Warnings Section Warnings

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