Saniwash Antimicrobial
Chloroxylenol
Safetec Of America, Inc.
Human Otc Drug
NDC 61010-1122Saniwash Antimicrobial also known as Chloroxylenol is a human otc drug labeled by 'Safetec Of America, Inc.'. National Drug Code (NDC) number for Saniwash Antimicrobial is 61010-1122. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Saniwash Antimicrobial drug includes Chloroxylenol - .006 mg/mL . The currest status of Saniwash Antimicrobial drug is Active.
Drug Information:
| Drug NDC: | 61010-1122 |
| 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: | Saniwash Antimicrobial |
| 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: | Chloroxylenol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Safetec Of America, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | CHLOROXYLENOL - .006 mg/mL
|
| 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: | 22 Apr, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Jun, 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: | part333A |
| 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: | Safetec of America, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 0F32U78V2Q
|
| 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 |
|---|
| 61010-1122-3 | 473 mL in 1 BOTTLE, PUMP (61010-1122-3) | 22 Apr, 2014 | N/A | No |
| 61010-1122-6 | 3785 mL in 1 BOTTLE, PUMP (61010-1122-6) | 22 Apr, 2014 | N/A | No |
| 61010-1122-7 | 208198 mL in 1 DRUM (61010-1122-7) | 22 Apr, 2014 | 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 antiseptic
Product Elements:
Saniwash antimicrobial chloroxylenol chloroxylenol chloroxylenol aloe vera leaf sodium laureth-3 sulfate coco diethanolamide cocamidopropyl betaine propylene glycol propylparaben methylparaben diazolidinyl urea water sodium chloride edetate sodium .alpha.-tocopherol acetate
Indications and Usage:
Uses for handwashing to decrease bacteria on the skin. recommended for repeated use.
Warnings:
Warnings for external use only when using this product supervise children under 6 do not use in the eyes. if contact occurs, rinse thoroughly with water stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours. keep out of reach of children. if swallowed get medical help or contact a poison control center right away.
When Using:
When using this product supervise children under 6 do not use in the eyes. if contact occurs, rinse thoroughly with water
Dosage and Administration:
Directions wet hands and forearms. apply 5 milliliters (teaspoonful) or palmful to hands and forearms. scrub thoroughly for 30 seconds. rinse and repeat.
Stop Use:
Stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours.
Package Label Principal Display Panel:
Principal display panel - 1 gallon bottle ndc 61010-1122-6 safetec saniwash antimicrobial hand soap effective against germs cleans dirty hands yet gentle on skin mild pleasant fragrance with aloe reorder no. 34455 net contents 1 gal (3.785 l) principal display panel - 1 gallon bottle
Principal display panel - 800 ml bag-in-box manufactured by safetec safetec of america, inc. buffalo, ny 14215 1-800-456-7077 www.safetec.com reorder no. 34465 ndc 61010-1122-4 27.05 fl. oz. (800 ml.) saniwash antimicrobial hand soap principal display panel - 800 ml bag-in-box
Principal display panel - 16 oz. bottle ndc 61010-1122-3 saniwash antimicrobial hand soap effective against germs cleans dirty hands yet gentle on skin mild pleasant fragrance with aloe net contents 16 fl. oz. (473 ml) safetec reorder no. 34452 principal display panel - 16 oz. bottle
Principal display panel - bottle label ndc 61010-1122-7 safetec saniwash ® antimicrobial hand soap effective against germs cleans dirty hands yet gentle on skin mild pleasant fragrance with aloe net contents 55 gal (208.2 l) reorder no. 34457 manufactured by safetec of america, inc. buffalo, ny 14215 800-456-7077 www.safetec.com principal display panel - bottle label