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Product NDC Code | 55910-344 | ||||
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Drug Name | Dg anti-itch |
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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 | ||||
Application Number | part348 | ||||
Labeler Name | Dollar General | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Purposes Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant
Diphenhydramine hydrochloride 2% | Topical analgesic |
Zinc acetate 0.1% | 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.Directions do not use more than directed adults and children 2 years of age and older: apply to affected area up 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 cetearyl alcohol (and) polysorbate 60, DMDM hydantoin, glyceryl stearate, isopropyl myristate, mineral oil, phenoxy ethenol, purified water, sodium benzoate
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 relieves pain and itching associated with: insect bites minor burns sunburn scrapes minor skin irritations minor cuts Dries the oozing and weeping of poison ivy, poison oak and poison sumac
Purpose
Information about the drug product’s indications for use.Active ingredients Purposes Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant
Diphenhydramine hydrochloride 2% | Topical analgesic |
Zinc acetate 0.1% | Skin protectant |
Spl product data elements
Usually a list of ingredients in a drug product.DG Anti-Itch Diphenhydramine hydrochloride and Zinc acetate Diphenhydramine hydrochloride diphenhydramine Zinc acetate zinc cation CETOSTEARYL ALCOHOL polysorbate 60 DMDM HYDANTOIN GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE PHENOXYETHANOL mineral oil Sodium Benzoate WATER
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 - 28 g Tube Carton DG™|health NDC 55910-344-24 Compare to active ingredients of Benadryl ® Extra Strength Cream* Extra Strength Anti-Itch Cream Topical Analgesic and Skin Protectant Relieves Itches From Insect Bites & Skin Irritations NET WT 1 OZ (28 g) PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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.Drug Facts
DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE GOODLETTSVILLE, TN 37072
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 more than directed on large areas of the body with any 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: 800-222-1222.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-309-9030
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 or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days
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 15 to 30°C (59 to 86°F) contents filled by weight, not volume Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
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. Avoid contact with eyes. Do Not Use more than directed on large areas of the body with any product containing diphenhydramine even one taken by mouth Ask a doctor before use on chicken pox on measles Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
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