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| Product NDC Code | 65692-0311 | ||||
|---|---|---|---|---|---|
| Drug Name | Okeeffes healthy feet pain relief cream |
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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 | LOTION | ||||
| RxCUI drug identifier | 2594492 | ||||
| Application Number | M017 | ||||
| Labeler Name | Raining Rose, 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 Allantoin 0.5% Lidocaine HCI 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 • adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. • children under 12 years of age: consult a doclor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Starch Octenylsuccinate, Beeswax, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Dimelhicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, 1,2 Hexanediol, Isopropyl Myrislate, Laureth-12, PEG-100 Stearate, Peppermint (Mentha Piperita) Oil, Phenoxyethanol, Polysilicone-11, Shea (Butyrospermum Parkii) Butter, Sodium Hydroxide, Water, Xanthan Gum
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 temporarily • relieves pain and itching associated with minor skin irritations • protects and helps relieve chapped or cracked skin
Purpose
Information about the drug product’s indications for use.Purposes Allantoin 0.5% .........Skin protectant Lidocaine HCI4% ....Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.OKeeffes Healthy Feet Pain Relief Cream Pain Relief Cream ALLANTOIN ALLANTOIN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE WATER GLYCERIN CETYL ALCOHOL ALUMINUM STARCH OCTENYLSUCCINATE PEPPERMINT OIL CETOSTEARYL ALCOHOL DODECAMETHYLPENTASILOXANE ISOPROPYL MYRISTATE SHEA BUTTER POLYOXYL 20 CETOSTEARYL ETHER WHITE WAX XANTHAN GUM DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) LAURETH-12 PHENOXYETHANOL ETHYLHEXYLGLYCERIN 1,2-HEXANEDIOL CAPRYLYL GLYCOL GLYCERYL 1-STEARATE PEG-100 STEARATE EDETATE DISODIUM ANHYDROUS CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SODIUM HYDROXIDE
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 Package O'KEEFFE'S FOR HEALTHY FEET Net Wt. 3 oz. (85 g) Distributed by: O'Keeffe's Company, Cincinnati, OH 45241 Questions/Comments: 1-800-275-2718 Carton Tube res HlthyFt Carton HlthyFt Tube
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 reach of children. If swallowed, get medical help or contact a Poison Control Center righl away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Child-resistant packaging. Store with lid closed tightly.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a heallh 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 quantilies, particularly over raw surfaces or blistered areas. • on deep or puncture wounds, animal biles or serious burns When using this product avoid conlacl with eyes Stop use and ask a doctor if • condilion worsens • symploms last more Ihan 7days or clear up and occur again wilhin afew days
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