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| Product NDC Code | 41167-0641 | ||||
|---|---|---|---|---|---|
| Drug Name | Gold bond extra strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 1293193 | ||||
| Application Number | M017 | ||||
| Labeler Name | Chattem, 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 Menthol 0.5%
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 and older: apply to affected area up to 3 or 4 times daily children under 2 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, dimethicone, glycerin, petrolatum, aloe barbadensis leaf juice, cetyl alcohol, stearyl alcohol, propylene glycol, stearamidopropyl PG-dimonium chloride phosphate, distearyldimonium chloride, cetearyl alcohol, polysorbate 60, steareth-21, steareth-2, tocopheryl acetate, EDTA, imidazolidinyl urea, methylparaben, potassium hydroxide, fragrance
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 the pain and itching associated with: minor skin irritations minor burns minor cuts insect bites sunburn scrapes
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Gold Bond Extra Strength Menthol MENTHOL MENTHOL WATER DIMETHICONE GLYCERIN PETROLATUM ALOE VERA LEAF CETYL ALCOHOL STEARYL ALCOHOL PROPYLENE GLYCOL STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE DISTEARYLDIMONIUM CHLORIDE CETOSTEARYL ALCOHOL POLYSORBATE 60 STEARETH-21 STEARETH-2 .ALPHA.-TOCOPHEROL ACETATE, D- EDETATE DISODIUM IMIDUREA METHYLPARABEN POTASSIUM 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 PANEL GOLD BOND ® EXTRA STRENGTH BODY LOTION Triple Action Relief For Extra Dry & Itchy Skin Net wt 14 oz (396 g) GOLD BOND® EXTRA STRENGTH BODY LOTION Triple Action Relief For Extra Dry & Itchy Skin Net wt 14 oz (396 g)
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 – Extra Strength Gold Bond Body Lotion
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 on deep or puncture wounds animal bites serious burns large areas of the body
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 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 redness, irritation, swelling or pain persists or increases
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 do not get into eyes or nose not for prolonged 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 on deep or puncture wounds animal bites serious burns large areas of the body When using this product do not get into eyes or nose not for prolonged use 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 redness, irritation, swelling or pain persists or increases Keep out of reach of children. 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