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| Product NDC Code | 41167-0507 | ||||
|---|---|---|---|---|---|
| Drug Name | Gold bond intensive relief anti-itch |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 1293905 | ||||
| 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% Pramoxine hydrochloride 1%
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 freely 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, glycerin, dimethicone, cetyl alcohol, petrolatum, distearyldimonium chloride, aloe barbadensis leaf juice, glyceryl stearate, stearyl alcohol, cetearyl alcohol, behentrimonium methosulfate, steareth-21, propylene glycol, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, diazolidinyl urea, butylene glycol, tocopheryl acetate, potassium hydroxide, methylparaben, panthenol, ethoxydiglycol, EDTA, avena sativa (oat) kernel extract
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 and itching associated with: ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Gold Bond Intensive Relief Anti-Itch Pramoxine Hydrochloride, Menthol PRAMOXINE HYDROCHLORIDE PRAMOXINE MENTHOL MENTHOL WATER GLYCERIN DIMETHICONE CETYL ALCOHOL PETROLATUM DISTEARYLDIMONIUM CHLORIDE ALOE VERA LEAF GLYCERYL MONOSTEARATE STEARYL ALCOHOL CETOSTEARYL ALCOHOL BEHENTRIMONIUM METHOSULFATE STEARETH-21 PROPYLENE GLYCOL POLYSORBATE 60 STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE DIAZOLIDINYL UREA BUTYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE POTASSIUM HYDROXIDE METHYLPARABEN PANTHENOL DIETHYLENE GLYCOL MONOETHYL ETHER EDETIC ACID OAT
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 ANTI-ITCH LOTION INTENSIVE RELIEF Net wt 5.5 oz (155 g) GOLD BOND ANTI-ITCH LOTION INTENSIVE RELIEF Net wt 5.5 oz (155 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.GOLD BOND® Medicated Intensive Relief Anti-Itch Lotion 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 immediately.
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
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 ■ avoid contact with eyes
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 When using this product ■ avoid contact with eyes 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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