Itch And Bite Relief First Aid Kit
Hydrocortisone And Diphenhydramine Hydrochloride
Wal-mart Stores, Inc.
Human Otc Drug
NDC 49035-588Itch And Bite Relief First Aid Kit also known as Hydrocortisone And Diphenhydramine Hydrochloride is a human otc drug labeled by 'Wal-mart Stores, Inc.'. National Drug Code (NDC) number for Itch And Bite Relief First Aid Kit is 49035-588. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Itch And Bite Relief First Aid Kit drug includes . The currest status of Itch And Bite Relief First Aid Kit drug is Active.
Drug Information:
| Drug NDC: | 49035-588 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Itch And Bite Relief First Aid Kit |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydrocortisone And Diphenhydramine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Mar, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 10 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | WAL-MART STORES, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106258
1049630
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0017276235883
|
| UPC stands for Universal Product Code. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 49035-588-09 | 1 KIT in 1 CASE (49035-588-09) * .9 g in 1 POUCH (61010-5800-1) * 1 TABLET, FILM COATED in 1 PACKET (47682-184-46) | 30 Oct, 2019 | 12 Mar, 2025 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose (hydrocortisone cream) anti-itch
Product Elements:
Itch and bite relief first aid kit hydrocortisone and diphenhydramine hydrocortisone hydrocortisone methylparaben water hydrocortisone hydrocortisone mineral oil paraffin petrolatum propylparaben cetostearyl alcohol polysorbate 60 peg-150 distearate steareth-20 alcohol medique diphen diphenhydramine hydrochloride cellulose, microcrystalline hypromelloses titanium dioxide croscarmellose sodium d&c red no. 27 lactose polyethylene glycol, unspecified silicon dioxide diphenhydramine hydrochloride diphenhydramine magnesium stearate pink 048;d oval itch and bite relief first aid kit hydrocortisone and diphenhydramine hydrochloride hydrocortisone hydrocortisone polysorbate 60 peg-150 distearate steareth-20 alcohol methylparaben petrolatum water propylparaben hydrocortisone hydrocortisone mineral oil paraffin cetostearyl alcohol medique diphen diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine cellulose, microcrystalline croscarmellose sodium croscarmellose magnesium stearate carnauba wax dibasic calcium phosphate dihydrate titanium dioxide d&c red no. 27 hypromelloses polysorbate 80 silicon dioxide polyethylene glycol, unspecified pink 061;t oval
Indications and Usage:
Uses (hydrocortisone cream) ⢠for temporary relief of itching associated with minor skin irritations, inflammation, or rashes due to: ⢠eczemas ⢠insect bites ⢠poison ivy, oak or sumac ⢠soaps ⢠detergents ⢠cosmetics ⢠jewelry ⢠seborrheic dermatitis ⢠psoriasis ⢠other uses of product should be only under the advice and supervision of a doctor.
Uses (diphen caplet) temporarily relieves these symptoms due to hay fever or other respiratory allergies ⢠runny nose ⢠sneezing ⢠itching of the nose or throat ⢠itchy, watery eyes temporarily relieves these symptoms due to the common cold ⢠runny nose ⢠sneezing
Warnings:
Warnings (hydrocortisone cream) for external use only do not use (hydrocortisone cream) ⢠in the eyes ⢠for treatment of diaper rash ⢠for feminine itching ask a doctor before use if you are (hydrocortisone cream) ⢠using any other hydrocortisone product stop use and ask a doctor if (hydrocortisone cream) the condition worsens or lasts more than 7 days, or clears up and occurs again within a few days keep out of reach of children (hydrocortisone cream) if ingested, contact a poison control center right away
Warnings (diphen caplet) do not use ⢠to make children sleepy ⢠with any other product containing diphenhydramine, even one that is used on skin. ask a doctor before use if you have (diphen caplet) ⢠a breathing problem such as emphysema or chronic bronchitis ⢠difficulty in urination due to enlargement of the prostate gland ⢠glaucoma when using this product (diphen caplet) ⢠marked drowsiness may occur ⢠avoid alcohol beverages ⢠alcohol, sedatives and tranquilizers may increase the drowsiness effect ⢠use caution when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children if pregnant or breast-feeding (diphen caplet) ask a health care professional before use. keep out of reach of children (diphen caplet) n case of overdose, contact a physician or poison control center immediately.
Do Not Use:
Warnings (hydrocortisone cream) for external use only do not use (hydrocortisone cream) ⢠in the eyes ⢠for treatment of diaper rash ⢠for feminine itching ask a doctor before use if you are (hydrocortisone cream) ⢠using any other hydrocortisone product stop use and ask a doctor if (hydrocortisone cream) the condition worsens or lasts more than 7 days, or clears up and occurs again within a few days keep out of reach of children (hydrocortisone cream) if ingested, contact a poison control center right away
Warnings (diphen caplet) do not use ⢠to make children sleepy ⢠with any other product containing diphenhydramine, even one that is used on skin. ask a doctor before use if you have (diphen caplet) ⢠a breathing problem such as emphysema or chronic bronchitis ⢠difficulty in urination due to enlargement of the prostate gland ⢠glaucoma when using this product (diphen caplet) ⢠marked drowsiness may occur ⢠avoid alcohol beverages ⢠alcohol, sedatives and tranquilizers may increase the drowsiness effect ⢠use caution when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children if pregnant or breast-feeding (diphen caplet) ask a health care professional before use. keep out of reach of children (diphen caplet) n case of overdose, contact a physician or poison control center immediately.
When Using:
When using this product (diphen caplet) ⢠marked drowsiness may occur ⢠avoid alcohol beverages ⢠alcohol, sedatives and tranquilizers may increase the drowsiness effect ⢠use caution when driving a motor vehicle or operating machinery ⢠excitability may occur, especially in children
Dosage and Administration:
Directions (hydrocortisone cream) ⢠apply to affected area not more than 3 to 4 times daily ⢠children under 2: ask a doctor
Directions (diphen caplet) ⢠do not take more than directed adults and children (12 years and older): take 1 to 2 caplets every 4 to 6 hours as needed. do not take more than 12 caplets in 24 hours, or as directed by a doctor. children under 12 years: do not give to children under 12 years of age.
Stop Use:
Stop use and ask a doctor if (hydrocortisone cream) the condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
Package Label Principal Display Panel:
First aid kit package/label principal display panel ozark trail outdoor equipment itch & bite relief first aid kit ideal for minor insects bites and itches 9 pieces see back panel for kit contents package label
First aid kit pakcage/label principal display panel ozark trail outdoor equipment itch & bite relief first aid kit ideal for minor insects bites and itches 9 pieces see back panel for kit contents label