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| Product NDC Code | 69822-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Ice quake |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1311523 | ||||
| Application Number | M017 | ||||
| Labeler Name | Southern Sales & Service, 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 Menthol 15%
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 apply to affected area not more than 3 to 4 tmes daily. Adults and children 18 years of age and older: consult a doctor. Children under 18 years of age:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerine, FD&C blue no. 1, carbopol, hydroxypropyl methylcellulose, isopropyl alcohol, propylene glycol, methylparaben, sodium hydroxide, purified 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 temporary relief of minor pain associated with: arthritis simple backache strains sprains bruises
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Ice Quake Menthol GLYCERIN FD&C BLUE NO. 1 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HYPROMELLOSE, UNSPECIFIED ISOPROPYL ALCOHOL PROPYLENE GLYCOL METHYLPARABEN SODIUM HYDROXIDE WATER MENTHOL MENTHOL
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.IceQuake Pain Relieving Gel 113g IceQuake Pain Relieving Gel 4 oz 113g
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
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 the reach of children. 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 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 do not bandage tightly do not apply to wounds or damaged skin.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 Avoid contact with eyes. For external use only. When using this product do not bandage tightly do not apply to wounds or damaged skin. 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 breast-feeding, ask a health professional before use. Keep out of the 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