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Diphenhydramine hcl and zinc acetate - Medication Information

Product NDC Code 41250-058
Drug Name

Diphenhydramine hcl and zinc acetate

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE],
Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Diphenhydramine hydrochloride 1.52 g/76g
Zinc acetate .076 g/76g
Route TOPICAL
Dosage Form SPRAY
RxCUI drug identifier 1053138
Application Number M017
Labeler Name Meijer Distribution Inc
Packages
Package NDC Code Description
41250-058-30 76 g in 1 can (41250-058-30)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Diphenhydramine HCl 2.0%, 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 do not use more often than directed adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
​Inactive ingredients aloe barbadensis leaf juice, glycerin, purified water, SD alcohol 40-B, tromethamine

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 the temporary relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak and poison sumac dries the oozing and weeping of poison ivy, poison oak and poison sumac

Purpose

Information about the drug product’s indications for use.
​Purpose External analgesic Skin protectant

Spl product data elements

Usually a list of ingredients in a drug product.
Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief WATER GLYCERIN ALCOHOL TROMETHAMINE ALOE VERA LEAF 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.
Principal Display Panel meijer CONTINUOUS itch relief spray Diphenhydramine HCl Zinc Acetate External Analgesic Skin Protectant EXTRA STRENGTH Relieves Itching from insect bites and poison ivy, oak & sumac Soothes sunburn and minor burns & cuts NET WT 2.7 OZ (76 g) image 1

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 on large areas of the body with any other product containing diphenhydramine, even one taken by mouth

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
​Other information store between 20° to 25°C (68° to 77°F)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
​Questions? call 1-866-964-0939

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 doctor if conditions 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

Safe handling warning

Safe Handling Warning
Flammable: Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

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. Flammable: Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox on measles When using this product avoid contact with eyes Stop use and ask doctor if conditions 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 right away.

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