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| Product NDC Code | 84615-006 | ||||
|---|---|---|---|---|---|
| Drug Name | Pomg pain relief body |
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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 | CREAM | ||||
| Application Number | M017 | ||||
| Labeler Name | POMG LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Lidocaine USP 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: rub a thin film over desired area not more than 3 to 4 times daily • Children under 12 years of age: consult a doctor • If using on hands, avoid contact with eyes and mouth
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients organic shea butter, organic aloe vera juice, organic mango butter, organic beeswax, organic cocoa butter (unscented), emu oil, organic grapeseed oil, organic sweet almond oi l,* organic jojoba oil, organic apricot kernel oil,* organic avocado oil, organic hempseed oil, organic rosehip oil, organic argan oil.* *Allergy Information: This product contains tree nuts (almond, argan, and apricot kernel)
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.Use For temporary relief of pain in muscles, joints, and tendons Can also be used for minor burns and bug bites
Purpose
Information about the drug product’s indications for use.Purpose Lidocaine USP 4%................Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.POMG PAIN RELIEF BODY Lidocaine ALMOND OIL EMU OIL SHEA BUTTER BEESWAX GRAPE SEED OIL APRICOT KERNEL OIL LIDOCAINE LIDOCAINE MANGIFERA INDICA SEED BUTTER ARGAN OIL COCOA BUTTER CANNABIS SATIVA SEED OIL ALOE VERA LEAF AVOCADO OIL ROSA CANINA FRUIT OIL JOJOBA OIL
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.NDC: 84615-006-05 Lidocaine 4% P.O.M.G. Pharmaceutical Organic Medicine Group Pain Relief Body Cream Organic Maximum Strength Lidocaine Without a Prescription Refreshes and Rejuvinates All Skin Types 5 oz (148 mL) 1 2
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 • If you are allergic to any ingredients in this product • On open sores and wounds • In large quantities
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 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 consult a doctor if • Conditions worsen or symptoms persist for more than 7 days • Symptoms clear up and occur again within a few days • Redness is present or excessive skin irritation occurs • You experience severe burning pain, swelling, or blistering where product was applied • Allergic reaction occurs
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 • Use only as directed • Avoid contact with eyes and other mucous membranes
Pregnancy or breast feeding
Pregnancy or Breast feeding• If pregnant or breast-feeding, consult with a doctor 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 • If you are allergic to any ingredients in this product • On open sores and wounds • In large quantities When using this product • Use only as directed • Avoid contact with eyes and other mucous membranes Stop use and consult a doctor if • Conditions worsen or symptoms persist for more than 7 days • Symptoms clear up and occur again within a few days • Redness is present or excessive skin irritation occurs • You experience severe burning pain, swelling, or blistering where product was applied • Allergic reaction occurs • If pregnant or breast-feeding, consult with a doctor before use • Keep out of reach of children and pets. If swallowed, get medical help or contact 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