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| Product NDC Code | 55621-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Family wellness |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1087026 | ||||
| Application Number | M017 | ||||
| Labeler Name | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ||||
| 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 Diphenhydramine hydrochloride 2 % Zinc acetate 0.1 %
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 -for adults and children over 2 years of age: apply to affected area not more than 3 or 4 times per day -children under 2 years of age: ask a doctor before use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients - cetyl alcohol, glycerol stearate, laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearyl alcohol, water
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 for temporary relief from pain and itching associated with insect bites, sunburn and minor skin irritations. Dries the oozing and weeping of poison: -ivy -oak - sumac
Purpose
Information about the drug product’s indications for use.Purpose ---Topical analgesic ---Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CETYL ALCOHOL GLYCERYL MONOSTEARATE LAURETH-23 METHYLPARABEN MINERAL OIL PETROLATUM PROPYLENE GLYCOL PROPYLPARABEN STEARIC ACID STEARYL ALCOHOL WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE ZINC CATION
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.copy of label
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 a doctor before use -on chicken pox -on measles
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 -over large areas of the body -with any other product containing diphenhydramine, including those taken orally
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST
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: -symptoms last for more than 7 days -the condition gets worse -symptoms clear up and then 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
Storage and handling
Information about safe storage and handling of the drug product.Other information - store at room temperature 59 - 86 F (15 - 30 C)
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