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Product NDC Code | 79481-0048 | ||||||
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Drug Name | Meijer pain relief cream |
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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 | CREAM | ||||||
RxCUI drug identifier | 1421893 | ||||||
Application Number | M017 | ||||||
Labeler Name | Meijer Distribution | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocaine HCI 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.Directions ■ adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. ■ Children 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient aloe vera leaf, aminomethylpropanol, carbomer interpolymer type A, cyclopentasiloxane 5, dihexadecyl phosphate, dimethicone, dimethicone/vinyl dimethicone crosspolymer, edetate disodium, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, SD alcohol, 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.Uses Temporarily relieves minor 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.Meijer Pain Relief Cream Lidocaine WATER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) CYCLOMETHICONE 5 GLYCERYL 1-STEARATE LIDOCAINE LIDOCAINE CARBOMER INTERPOLYMER TYPE A (55000 CPS) ALOE VERA LEAF DIMETHICONE EDETATE DISODIUM ETHYLHEXYLGLYCERIN ALCOHOL PHENOXYETHANOL DIHEXADECYL PHOSPHATE STEARETH-21 ISOHEXADECANE AMINOMETHYLPROPANOL
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.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.Do not use ■ on large areas of the body or cut, irritated, or swollen skin ■ on puncture wounds ■ for more than one week without consulting a doctor
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 Poison Control Center (1-800-222-1222) right away.
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
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 1-866-326-1313
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 persist 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 ■ use only as directed. Read and follow all directions and warnings on this carton ■ do not allow contact with the eyes ■ do not bandage or apply local heat (such as heating pads) to the area of use
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding 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. Avoid contact with eyes. Do not use ■ on large areas of the body or cut, irritated, or swollen skin ■ on puncture wounds ■ for more than one week without consulting a doctor When using this product ■ use only as directed. Read and follow all directions and warnings on this carton ■ do not allow contact with the eyes ■ do not bandage or apply local heat (such as heating pads) to the area of use Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breastfeeding ask a health professional before use Keep out of reach of children and pets If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) 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