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| Product NDC Code | 54273-011 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Zims max freeze leg cramp |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 2610291 | ||||||
| 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 3.1% Topical analgesic Menthol 5% Topical analgesic Methyl Salicylate 11.5% Topical analgesic
| Camphor 3.1% | Topical analgesic |
| Menthol 5% | Topical analgesic |
| Methyl Salicylate 11.5% | 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: apply to affected area not more than 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 Dimethyl Isosorbide, Propylene Glycol, SD Alcohol 40-B, Tea Tree Oil, Tocopheryl Acetate, Water, Zingiber Officinale (Ginger) Root Extract.
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 3.1% Topical analgesic Menthol 5% Topical analgesic Methyl Salicylate 11.5% Topical analgesic
| Camphor 3.1% | Topical analgesic |
| Menthol 5% | Topical analgesic |
| Methyl Salicylate 11.5% | Topical analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.ZIMS MAX FREEZE LEG CRAMP Menthol CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE SALICYLIC ACID DIMETHYL ISOSORBIDE PROPYLENE GLYCOL ALCOHOL TEA TREE OIL .ALPHA.-TOCOPHEROL ACETATE WATER GINGER
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 - 89 mL Bottle Carton ZIM'S™ MAX- FREEZE For Minor Pain Caused by LEG CRAMPS Relax & Relieve Muscles Fast Acting Liquid Easy to Use Angled Bottle Pain Relieving Liquid 3 fl oz (89mL) 3 POWERFUL INGREDIENTS PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton
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 if you are allergic to any ingredient in this product on open wounds, damaged or irritated skin 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 immediately.
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 rash, itching, redness, or excessive irritation, burning sensation, swelling or blistering 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 to avoid excess application, press applicator gently against skin do not bandage tightly or cover with wrap or use heating pad or TENS device do not use 1 hour prior to bathing or within 30 minutes after bathing do not use other than as directed avoid contact with eyes or mucous membranes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf you are pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use store in a cool place away from direct sunlight store with cap closed tightly
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 Flammable Keep away from fire or flame and heated surfaces Do not use if you are allergic to any ingredient in this product on open wounds, damaged or irritated skin after expiration date When using this product to avoid excess application, press applicator gently against skin do not bandage tightly or cover with wrap or use heating pad or TENS device do not use 1 hour prior to bathing or within 30 minutes after bathing do not use other than as directed avoid contact with eyes or mucous membranes Stop use and ask a doctor if condition worsens rash, itching, redness, or excessive irritation, burning sensation, swelling or blistering of the skin develops symptoms persist for more than 7 days symptoms clear up and occur again within a few days If you are pregnant or breastfeeding, 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 immediately.
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