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| Product NDC Code | 66902-165 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Icy freeze |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 808955 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | NATURAL ESSENTIALS, 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 ingredient Menthol 3.5%
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/Children 2 years and older: Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine. MADE IN USA for Healer Health LLC Zionsville, Indiana 46077 TM Reg'd 85140-L ICYFREEZE.COM
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 Temporary relief from minor aches and pains associated with: Tendonitis Strains Sprains Sore muscles Joint discomfort Arthritis
Purpose
Information about the drug product’s indications for use.Purpose Cooling Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.ICY FREEZE MENTHOL MENTHOL MENTHOL ALOE VERA LEAF CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL METHYLPARABEN TROLAMINE 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 - Icy Freeze 3oz Gel Pump FREEZES PAIN THERAPUTIC PAIN RELIEF Greaseless and stain free with Aloe, Vitamin E and Ilex NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT ICY FREEZE COOLING PAIN RELIEF FOR TENDONITIS, ARTHRITIS, SPRAINS AND STRAINS GEL 4 FL OZ (120 mL) Principal Display Panel - Icy Freeze 3oz Gel Pump
Principal Display Panel - Icy Freeze 3oz Roll On FREEZES PAIN THERAPUTIC PAIN RELIEF Greaseless and stain free with Aloe, Vitamin E and Ilex NATURAL INGREDIENTS • SOOTHING MENTHOL • VANISHING SCENT ICY FREEZE COOLING PAIN RELIEF FOR TENDONITIS, ARTHRITIS, SPRAINS AND STRAINS ROLL-ON 3 FL OZ (90 mL) Principal Display Panel - Icy Freeze 3oz Roll On
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.ICY FREEZE COOLING PAIN RELIEF Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you Have sensitive skin Are pregnant or breastfeeding
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 With heating pad or device With creams, ointments, sprays or liniments On wounds, damaged skin or irritated skin
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Replace cap after use Store in a cool, dry place.
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 then reoccur again within a few days Irritation develops
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 Avoid contact with eyes or mucous membranes Do not bandage 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 excessive heat or open flame Do not use With heating pad or device With creams, ointments, sprays or liniments On wounds, damaged skin or irritated skin Ask a doctor before use if you Have sensitive skin Are pregnant or breastfeeding When using this product Avoid contact with eyes or mucous membranes Do not bandage tightly Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up then reoccur again within a few days Irritation develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Adults/Children 2 years and older: Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes Children under 2 years old: Application should be supervised by an adult. Other information Replace cap after use Store in a cool, dry place. Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine. MADE IN USA for Healer Health LLC Zionsville, Indiana 46077 TM Reg'd 85140-L ICYFREEZE.COM
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