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| Product NDC Code | 41167-0392 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Gold bond medicated advanced healing |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1044967 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Chattem, Inc. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient
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 ■ for skin protectant use: apply as needed ■ for diaper rash use: ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients isopropyl palmitate, dimethicone, glyceryl stearate, butyrospermum parkii (shea) butter extract, silica, polyethylene, jojoba esters, ceramide NP, 7-dehydrocholesterol, isopropyl myristate, lavandula angustifolia (lavender) extract, rosmarinus officinalis (rosemary) leaf extract, acacia farnesiana flower extract, chamomilla recutita (matricaria) flower extract, tetrahexyldecyl ascorbate, pentylene glycol, 4-t-butylcyclohexanol, bisabolol, zingiber officinale (ginger) root extract, tocopheryl acetate, jojoba oil/macadamia seed oil esters, squalene, phytosteryl macadamiate, phytosterols, tocopherol, zea mays (corn) oil
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 protects minor ■ cuts ■ scrapes ■ burns ■ helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin and lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps treat and prevent diaper rash ■ protects chafed skin due to diaper rash and helps seal out wetness
Purpose
Information about the drug product’s indications for use.Purpose White petrolatum 45% Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Gold Bond Medicated Advanced Healing White Petrolatum PETROLATUM PETROLATUM ISOPROPYL PALMITATE DIMETHICONE GLYCERYL MONOSTEARATE SHEA BUTTER SILICON DIOXIDE HIGH DENSITY POLYETHYLENE CERAMIDE NP 7-DEHYDROCHOLESTEROL ISOPROPYL MYRISTATE LAVANDULA ANGUSTIFOLIA FLOWERING TOP ROSEMARY VACHELLIA FARNESIANA FLOWER CHAMOMILE TETRAHEXYLDECYL ASCORBATE PENTYLENE GLYCOL 4-TERT-BUTYLCYCLOHEXANOL LEVOMENOL GINGER .ALPHA.-TOCOPHEROL ACETATE SQUALENE PHYTOSTERYL MACADAMIATE TOCOPHEROL CORN OIL JOJOBA OIL HYDROGENATED MACADAMIA SEED OIL HYDROLYZED JOJOBA ESTERS (ACID FORM)
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 Advanced Healing Skin Protectant Ointment Net Wt 1.75 oz PRINCIPAL DISPLAY PANEL GOLD BOND Advanced Healing Skin Protectant Ointment Net Wt 1.75 oz PRINCIPAL DISPLAY PANEL GOLD BOND Advanced Healing Skin Protectant Ointment Net Wt 1.75 oz
PRINCIPAL DISPLAY PANEL GOLD BOND Advanced Healing Skin Protectant Ointment Net Wt 7 oz PRINCIPAL DISPLAY PANEL GOLD BOND Advanced Healing Skin Protectant Ointment Net Wt 7 oz PRINCIPAL DISPLAY PANEL GOLD BOND Advanced Healing Skin Protectant Ointment Net Wt 7 oz
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 Advanced Healing Skin Protectant Ointment White Petrolatum 45% Drug Facts
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
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 last 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 Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ avoid contact with eyes Stop use and ask a doctor if ■ condition worsens ■ symptoms last 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