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| Product NDC Code | 54273-013 | ||||
|---|---|---|---|---|---|
| Drug Name | Zims max freeze leg cramps |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 2675766 | ||||
| Application Number | M017 | ||||
| Labeler Name | KOBAYASHI Healthcare International, Inc. | ||||
| 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 ingredients Purpose Camphor 5% Topical analgesic Menthol 5% Topical analgesic
| Camphor 5% | Topical analgesic |
| Menthol 5% | 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 Adults and children 12 years of age and over : clean and dry affected area remove film from patch and apply to the skin (see illustration) apply 1 patch at a time to affected area, not more than 3 to 4 times daily Children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Butyl Acrylate/Methacrylic acid copolymer, FD&C Blue No. 1, Glycerin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylparaben, Propylene glycol, Silicon dioxide, Sodium polyacrylate, Sodium polyacrylate starch, Sorbitan monooleate, Sorbitol, Tartaric acid, 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 For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Bruises Sprains Cramps
Purpose
Information about the drug product’s indications for use.Active ingredients Purpose Camphor 5% Topical analgesic Menthol 5% Topical analgesic
| Camphor 5% | Topical analgesic |
| Menthol 5% | Topical analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.ZIMS MAX FREEZE LEG CRAMPS CAMPHOR, MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM BUTYL ACRYLATE/METHACRYLIC ACID COPOLYMER (2% METHACRYLIC ACID) FD&C BLUE NO. 1 GLYCERIN METHYLPARABEN POLYACRYLIC ACID (300000 MW) POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN SODIUM POLYACRYLATE (2500000 MW) SODIUM POLYACRYLATE STARCH (25 MICROMETER PARTICLE) SORBITAN MONOOLEATE SORBITOL TARTARIC ACID SILICON DIOXIDE WATER
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.PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box ZIM'S™ MAX- FREEZE For Minor Pain Caused by LEG CRAMPS COOLING PAIN RELIEF HYDRO PATCH Immediate Cooling & Long-lasting Pain Relief While You Sleep* † APPLY for 8 Hours 5 PATCHES 3 15/16" X 5 1/2" (10 cm X 14 cm) †See back panel for important product information COOLING PAIN RELIEF HYDRO PATCH: Menthol & Camphor with thick Hydrogel PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box
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
Distributed by: KOBAYASHI Consumer Products, LLC P.O. Box 1191, Dalton, GA 30722
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 on your leg or arm at a time if you are allergic to any ingredients in this product on open wounds, damaged or irritated skin with a heating pad or TENS device or other topical analgesics after expiration date
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.
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 burning sensation is painful and persistent condition worsens rash, itching, redness, swelling, blistering or excessive irritation of the skin develops symptoms persist for more than 7 days symptoms 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 do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time if severe burning sensation occurs, discontinue use immediately may leave a blue stain on skin, which is safe and can be removed by washing with soap and water avoid adhering patch to clothes or delicate fabrics such as silk
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store in a place away from direct sunlight and excessive heat and moisture.
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 on your leg or arm at a time if you are allergic to any ingredients in this product on open wounds, damaged or irritated skin with a heating pad or TENS device or other topical analgesics after expiration date When using this product do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time if severe burning sensation occurs, discontinue use immediately may leave a blue stain on skin, which is safe and can be removed by washing with soap and water avoid adhering patch to clothes or delicate fabrics such as silk Stop use and ask a doctor if burning sensation is painful and persistent condition worsens rash, itching, redness, swelling, blistering or excessive irritation of the skin develops symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding , 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.
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