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| Product NDC Code | 30056-004 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Elgin pain relief |
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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 | Eco-Logics, 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.OTC-ACTIVE INGREDIENT SECTION Active Ingedients Purpose Menthol USP 3.5%................... Topical 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 ADirections: Adults and children 2 years of age and older: Apply to painful muscles and joints. Genthly massage thtoughly into affected areas. Repeat as necessary but not more than 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive Ingredients: Aqueou(Deionized water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *Ilex Paraguariensis Leaf Extract, Cinnamomum Camphora (camphor), Tocopheryl Acetate (Vitamin E Acetate) Carbomer, FDC Blue #1, FDC Yellow#5, Methylparaben, 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 USES: Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.
Directions Directions: Adults and children 2 years of age and older: Apply to painful muscles and joints. Genthly massage throughly into affected area. Repeat as necessary but not more than 4 times daily.
Purpose
Information about the drug product’s indications for use.Purpose Menthol USP 3.5%Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Elgin Pain Relief Menthol CAMPHOR (NATURAL) METHYLPARABEN TROLAMINE FD&C YELLOW NO. 5 ALOE VERA LEAF ISOPROPYL ALCOHOL ILEX PARAGUARIENSIS LEAF ALPHA-TOCOPHEROL FD&C BLUE NO. 1 WATER CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) MENTHOL MENTHOL
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.Principle Dislay Panel 30056-004-32 30056-004-28
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 doctor before use if you: Ask a doctor before use if you have sensitive 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: Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center.
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: Stop use and Ask doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.
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 When using this product: Avoid contact with the eyes or mucous membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or linaments. Do nopt apply to irrated skin or ifexcessive irration develops. Do not bandage. Wash hands after use with cool water. Do not use with heating pad or device.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding: If pregrant or breast feeding. Ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Other information: Store in a cool dry place with lid closed 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.Warning Warning For external Use only.
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