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Product NDC Code | 81522-953 | ||||
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Drug Name | Caring mill lidocaine aloe gel burn and pain relief |
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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 | LIQUID | ||||
RxCUI drug identifier | 1011849 | ||||
Application Number | M017 | ||||
Labeler Name | FSA Store Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Lidocaine Hydrochloride 0.5% Purpose External 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 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Hydroxide, Propylene Glycol, Glyceryl Acrylate/Acrylic Acid Copolymer, Carbomer, Phenoxyethanol, Polysorbate 20, Caprylyl Glycol, Allantoin, Panthenol, Citrus Limon (Lemon) Peel Extract, Mentha Viridis (Spearmint) Leaf Oil, Symphytum Officinale (Comfrey) Leaf Extract, Tocopheryl Acetate, 1,2-Hexanediol, Ethylhexylglycerin, Blue 1, Yellow 5.
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 pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.
Purpose
Information about the drug product’s indications for use.Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Caring mill Lidocaine Aloe Gel Burn and Pain Relief LIDOCAINE HYDROCHLORIDE WATER ALOE VERA LEAF GLYCERIN SODIUM HYDROXIDE PROPYLENE GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PHENOXYETHANOL POLYSORBATE 20 CAPRYLYL GLYCOL ALLANTOIN PANTHENOL LEMON PEEL SPEARMINT OIL SYMPHYTUM X UPLANDICUM LEAF .ALPHA.-TOCOPHEROL ACETATE 1,2-HEXANEDIOL ETHYLHEXYLGLYCERIN FD&C BLUE NO. 1 FD&C YELLOW NO. 5 LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE
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.Package Labeling: Label2
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
Other information Store between 68°F to 77°F (20°C to 25°). May stain some fabrics or surfaces
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. If product is swallowed, get medical help or contact a Poison Control Center right away.
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 Avoid contact with eyes If condition worsens , or if symptoms persist for more than 7 days or clear up and occur again with a few days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas. Keep out of reach of children. If product is 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