Anti-itch Wipes
Anti-itch Wipe
Diamond Wipes International
Human Otc Drug
NDC 64709-158Anti-itch Wipes also known as Anti-itch Wipe is a human otc drug labeled by 'Diamond Wipes International'. National Drug Code (NDC) number for Anti-itch Wipes is 64709-158. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Anti-itch Wipes drug includes Pramoxine Hydrochloride - 1 g/100g . The currest status of Anti-itch Wipes drug is Active.
Drug Information:
| Drug NDC: | 64709-158 |
| 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: | Anti-itch Wipes |
| 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: | Anti-itch Wipe |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Diamond Wipes International |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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: | PRAMOXINE HYDROCHLORIDE - 1 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 06 Jul, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| 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: | 31 Dec, 2023 |
| 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: | Diamond Wipes International
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1039541
|
| 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. |
| UNII: | 88AYB867L5
|
| 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 |
|---|
| 64709-158-20 | 1 POUCH in 1 BOX (64709-158-20) / 30 g in 1 POUCH | 06 Jul, 2022 | N/A | 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 external analgesic
Product Elements:
Anti-itch wipes anti-itch wipe hamamelis virginiana top water cocamidopropyl propylene glycol-dimonium chloride phosphate althaea officinalis root citric acid monohydrate phenoxyethanol .alpha.-tocopherol acetate glycerin limosilactobacillus fermentum sunflower oil lavender oil pramoxine hydrochloride pramoxine oat apple cider vinegar water rosa centifolia flower oil coconut chamomile polyglyceryl-4 caprate pomegranate aloe vera leaf cucumber disodium cocoamphodiacetate ethylhexylglycerin acai honey sodium chloride tetrasodium glutamate diacetate calendula officinalis flower toweltte
Indications and Usage:
Uses for the temporary relief of pain and itching associated with minor skin irritations
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product avoid contact with eyes.
Dosage and Administration:
Directions: adults and children 12 years of age and older:apply to affected area not more than 3 or 4 times daily. children under 12 years of age: consult a doctor
Package Label Principal Display Panel:
Label the honey pot company plant-derived feminine caretm anti-itch soothing wipes 1% pramoxine hydrochloride (external analgesic) for temporary relief of itching and discomfort relief 30 count maximum strength 8 50021 58936 3 poweredby herbs ® find us online: @thehoneypotco www.thehoneypot.co crueltyfree distributed by the honey pot co. p.o.box 93326 atlanta, ga 30377 thehoneypot.co made in usa with global components non-flushable made with witch hazel aloe calendula lavender the honey pot's first treatment line designed to relieve itch. try them all: ⦠anti-itch soothing spray ⦠anti-itch vulva cream ⦠soothing vulva wash* *when used as a regimen with anti-itch wipes, cream or spray. tamper evident unit, do not use if perforated flap has been opend, is missing or incompletely sealed made by humans with vaginas for humans with vaginas because it takes one to know one ® i was suffering with bacterial vaginosis for 8 months when an ancestor came to me in a dream and gifted me with a vision to heal myself. with her help i created the honey pot to solve for what other brands wouldn't - feminine care, powered by herbs ®. the honey pot company designed to relieve itch calendula aloe lavender relief powered by herbs ® 8 50021 58936 3 relief label label
Further Questions:
Questions: for questions and general information visit us at www. thehonypot.co/contact