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Product NDC Code | 69571-005 | ||||
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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 | FRONT PHARMACEUTICAL PLC | ||||
Packages |
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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 to 4 times daily •children under 2 years of age: ask a doctor before use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.cetyl alcohol, glyceryl stearate se, Inactive ingredients laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearic 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.for temprary relief from pain and itching associated Uses with insect bites , sunburn and mior 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 STEARATE SE 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.label image description
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.. If swallowed, get medical help Keep out of reach of children or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.store at room temperature 59° - 86° F Other information (15° - 30° C).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?
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 •avoid contact with eyes When using this product Ask a doctor before use •on chicken pox •on measles Stop use and ask a doctor if over large areas of the body with any other product containing diphenhydramine including those taken orally symptoms last for more than 7 days the condition gets worse symptoms clear up and then occur again within a few days
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