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| Product NDC Code | 66902-225 | ||||
|---|---|---|---|---|---|
| Drug Name | Fast freeze lidocaine |
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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 | SPRAY | ||||
| RxCUI drug identifier | 1869797 | ||||
| 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 INGREDIENTS Lidocaine 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 Shake well Adults and children over 12 years: Apply a thin layer to affected area not more than 3 to 4 times daily To apply to face, spray into palm of hand and gently apply Children under 12 years of age, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Acrylates/C10-30 Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Diazolidinyl Urea. Dimethicone, Disodium Cocamphodipropionate. Disodium EDTA, Glycerin. Propylene Glycol, SDA 39C Alcohol, Tocopheryl Acetate, Triethanolamine.
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 of 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.Fast Freeze Lidocaine LIDOCAINE LIDOCAINE LIDOCAINE CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) ALOE VERA LEAF MATRICARIA CHAMOMILLA FLOWERING TOP CUCUMBER WATER DIAZOLIDINYL UREA DIMETHICONE DISODIUM COCOAMPHODIPROPIONATE EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE
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 – 118 mL Can Label FAST FREEZE ® MAXIMUM STRENGTH LIDOCAINE CONTINUOUS SPRAY UNSCENTED Numbing relief No mess, greaseless & stain-free Natural ingredients include Vitamin E and Aloe For the temporary relief of minor aches and pains of muscles and joints; associated with backache, arthritis, strains and sprains Paraben Free Fast Drying 3 oz (89 mL) Principal Display Panel – 118 mL Can 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 In large quantities, particularly over raw surfaces or blistered areas
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 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 Keep out of eyes Use only as directed do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F
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 For external use only DO NOT USE In large quantities, particularly over raw surfaces or blistered areas WHEN USING THIS PRODUCT Keep out of eyes Use only as directed do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F 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 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