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| Product NDC Code | 69452-449 | ||||
|---|---|---|---|---|---|
| Drug Name | Itch relief |
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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 | Bionpharma 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 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 ■ children under 2 years of age: ask a doctor ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ do not use more than directed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60, propylparaben, purified water, stearic acid
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 ■ dries the oozing and weeping of poison ivy, poison oak, and poison sumac ■ temporarily relieves pain and itching associated with: ■ minor cuts ■ sunburn ■ scrapes ■ minor skin irritations ■ minor burns ■ insect bites ■ rashes due to poison ivy, poison oak and poison 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.itch relief diphenhydramine hydrochloride and zinc acetate WATER ZINC ACETATE ZINC CATION CARBOMER HOMOPOLYMER TYPE C CETYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE LIGHT MINERAL OIL METHYLPARABEN POLYSORBATE 60 PROPYLPARABEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE STEARIC ACID
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.tube carton * compare to the active ingredient in Benadryl® Extra Strength Itch Stopping Cream NDC 69452-449-37 a+ health TM itch relief cream diphenhydramine HCl 2 % + zinc acetate 0.1% net wt. 1.25 oz dye-free • phthalate-free • fragrance-free • extra strength • topical analgesic • skin protectant image001
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.READ AND KEEP CARTON FOR COMPLETE INFORMATION *This product is not manufactured or distributed by the owners of Benadryl® Extra Strength ItchStopping Cream. Manufactured for: Bionpharma Inc., Princeton, NJ 08540 MADE IN INDIA GUJ/DRUGS/G/25/2134 L0000814 R0424 LOT & EXP.
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 measles ■ on chicken pox ■ on poison ivy ■ on sunburn
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.
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
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 the eyes.
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) ■ Close the cap tightly after use ■ Lot No. & Exp. Date: See box or crimp of tube
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 ■ with any other product containing diphenhydramine, even one taken by mouth ■ on large areas of the body ■ on broken, blistered, or oozing skin
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