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Careland lidocaine 4 pain relieving gel-patches - Medication Information

Product NDC Code 75568-004
Drug Name

Careland lidocaine 4 pain relieving gel-patches

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine 40 mg/g
Route TOPICAL
Dosage Form PATCH
RxCUI drug identifier 1737778
Application Number M017
Labeler Name Planet (Anhui) Pharmaceutical Co., Ltd.
Packages
Package NDC Code Description
75568-004-01 1 bag in 1 box (75568-004-01) / 6 patch in 1 bag / 13 g in 1 patch
75568-004-02 1 bag in 1 box (75568-004-02) / 35 patch in 1 bag / 13 g in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Lidocaine 4.0% Purpose Topical anesthetic

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 12 years of age and over: clean and dry affected area apply 1 patch at a time to affected area, not more than 3 to 4 times daily remove film from patch and apply to the skin Children under 12 years of age: consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone K90, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, 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 For temporary relief of pain

Purpose

Information about the drug product’s indications for use.
Purpose Topical anesthetic

Spl product data elements

Usually a list of ingredients in a drug product.
Careland Lidocaine 4 Pain Relieving Gel-Patches LIDOCAINE DIHYDROXYALUMINUM AMINOACETATE GLYCERIN KAOLIN METHYLPARABEN POLYSORBATE 80 POVIDONE K90 PROPYLENE GLYCOL PROPYLPARABEN TARTARIC ACID TITANIUM DIOXIDE WATER LIDOCAINE LIDOCAINE

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.
Package Labeling:75568-004-01 Label2 Package Labeling:75568-004-02 Label

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.
DRUG FACTS OTHER INFORMATION store in a clean, dry place outside of direct sunlight, Protect product from excessive moisture

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.
Do not use more than 1 patch at a time with a heating pad on wounds or damaged skin ir you are allergic to any ingredients of this product

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 right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
QUESTIONS? 1-888-655-1558

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 symptoms persist for more than 7 days conditions worsen symptoms clear up and occur again within a few days localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop

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 use only as directed do not bandage tightly avoid contact with the eyes, mucous membranes or rashes

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast feeding, ask a health professional before use

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 Do not use more than 1 patch at a time with a heating pad on wounds or damaged skin ir you are allergic to any ingredients of this product When using this product use only as directed do not bandage tightly avoid contact with the eyes, mucous membranes or rashes Stop use and ask a doctor if symptoms persist for more than 7 days conditions worsen symptoms clear up and occur again within a few days localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop If pregnant or breast feeding, ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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