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| Product NDC Code | 63868-500 | ||||
|---|---|---|---|---|---|
| Drug Name | Quality choice maximum strength zinc oxide |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 244638 | ||||
| Application Number | part347 | ||||
| Labeler Name | Chain Drug Marketing Association 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 ingredient Zinc oxide 40%...........................Skin protectant
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.DISTRIBUTED BY: C.D.M.A., INC. 43157 W. NINE MILE NOVI, MI 48376 www.qualitychoice.com Made in China
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients .alpha.-tocopherol acetate, butylated hydroxytoluene, lanolin, lavender oil, light mineral oil, methylparaben, petrolatum, polysorbate 60
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.Directions change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged
Purpose
Information about the drug product’s indications for use.Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness
Spl product data elements
Usually a list of ingredients in a drug product.Quality Choice Maximum Strength Zinc Oxide Zinc Oxide .ALPHA.-TOCOPHEROL ACETATE LAVENDER OIL BUTYLATED HYDROXYTOLUENE POLYSORBATE 60 LANOLIN METHYLPARABEN PETROLATUM ZINC OXIDE ZINC CATION LIGHT MINERAL 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.99197.1
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 (1-800-222-1222) 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 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 do not get into eyes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20°-25°C (68°-77°F) may stain clothing
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
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