Certain Dri Roll-on
Aluminum Chloride
Denison Pharmaceuticals, Llc.
Human Otc Drug
NDC 0295-0122Certain Dri Roll-on also known as Aluminum Chloride is a human otc drug labeled by 'Denison Pharmaceuticals, Llc.'. National Drug Code (NDC) number for Certain Dri Roll-on is 0295-0122. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Certain Dri Roll-on drug includes Aluminum Chloride - .12 mg/mL . The currest status of Certain Dri Roll-on drug is Active.
Drug Information:
| Drug NDC: | 0295-0122 |
| 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: | Certain Dri Roll-on |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Certain Dri |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | ROLL-ON |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Aluminum Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Denison Pharmaceuticals, Llc. |
| 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: | ALUMINUM CHLORIDE - .12 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 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: | 01 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Dec, 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: | part350 |
| 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: | Denison Pharmaceuticals, LLC.
|
| 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: | 3CYT62D3GA
|
| 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 |
|---|
| 0295-0122-07 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0295-0122-07) / 35.5 mL in 1 BOTTLE, WITH APPLICATOR | 01 Jan, 2017 | N/A | No |
| 0295-0122-12 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0295-0122-12) / 59.15 mL in 1 BOTTLE, WITH APPLICATOR | 01 Jan, 2017 | 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:
Active ingredient purpose aluminum chloride 12.0% antiperspirant
Product Elements:
Certain dri roll-on aluminum chloride sodium hydroxide water aluminum chloride aluminum cation
Indications and Usage:
Uses extra effective at reducing underarm perspiration
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product do not use in or near eyes apply to underarms only
Dosage and Administration:
Directions apply to underarms only apply at bedtime, see package insert apply sparingly apply only a few strokes under each arm
Stop Use:
Stop use and ask a doctor if rash or irritation develops
Spl Patient Package Insert:
Package insert certain dri ® anti-perspirant directions for use important facts about perspiration problems the certain dri protection⢠system certain dri ® clarion brands, llc 27070 miles road, suite a solon, oh 44139 toll-free 1-844-923-7837 certain dri ® is a registered trademark of clarion brands, llc ab1002 certain dri ® anti-perspirant... the most effective anti-perspirant you can buy without a prescription. clinical strength certain dri ® roll-on contains aluminum chloride (a1c13), the ingredient prescribed by doctors to patients with hyperhidrosis or excessive perspiration. laboratory studies prove that aluminum chloride is more effective and longer lasting than other ingredients found in anti-perspirants. yet it is safe when used as directed. clinical strength certain dri ® solid contains aluminum sesquichlorohydrate, also effective for extended protection and better for individuals with more sensitive skin. important. because of its therapeutic ingredie
Read more...nts, clinical strength certain dri ® anti-perspirant is used differently from all other anti-perspirants. for maximum effect, it is important to follow directions very carefully . directions apply clinical strength certain dri ® anti-perspirant to underarms at bedtime. thatâs because clinical strength certain dri ® works while you sleep to shrink your pores so it can stop perspiration all day. it will not wash off the next day, even after bathing or showering. apply sparingly. like many other therapeutic products, clinical strength certain dri ® should be applied sparingly - only a few strokes under each arm. (1 to 2 for the roll-on, 4 to 6 for the solid as a start; more if necessary) you may not have to use clinical strength certain dri ® every day. you may wish to begin your treatment by using certain dri ® every day until excessive perspiration is controlled. thereafter, apply certain dri ® every other day or as needed. caution. do not use immediately after shaving or showering; or if skin is broken or irritated. skin area must be completely dry prior to application. discontinue use if rash develops. keep away from eyes. keep out of reach of children. warning: certain dri ® can discolor clothing if it is not completely dry. please allow 5 to 10 minutes for the product to dry, less for certain dri ® solid. what about morning or daytime use? clinical strength certain dri ® 72hr protection roll-on or solid work best when used at night. for extra freshness throughout the day, we have specially formulated everyday strength certain dri ® a.m. solid or roll-on antiperspirant as a companion just for morning use. pair one of the clinical strength formula products with either everyday strength certain dri ® a.m. product for prescription strength protection and daily freshness. all certain dri ® products are intended for use by both men and women. the certain dri protection system⢠if you suffer from excessive perspiration, the certain dri protection system⢠offers complete underarm security and confidence under all situations: at night to control excessive perspiration, use clinical strength certain dri ® anti-perspirant roll-on or solid in the morning for all day freshness and deodorant protections, use everyday strength certain dri ® a.m. facts about perspiration problems what causes perspiration? any of the following factors, separately or in combination, can cause varying amounts of perspiration: physical exertion; mental or emotional stress; warm or hot temperatures; nonporous, heavy clothing; obesity or endocrine dysfunction; inherited factors. why does perspiration occur? when your body âoverheatsâ as a result of any of the above factors, it activates the sweat glands, especially those in the underarm area (axillary glands), to produce perspiration which is emitted through your skin pores. the perspiration then evaporates to produce a cooling effect, thereby reducing the body's skin temperature. what causes underarm odor? in its freshly released state, perspiration is generally odorless. however, when it exists in a confined and damp underarm area, it decomposes and causes odor-producing bacteria to form. combined with natural salt and uric acid which are also emitted through the pores, the perspiration then takes on its familiar unpleasant odor. what is a deodorant? a deodorant is any kind of fragrance used to cover up or deodorize one odor with another. while perfumes are generally used, some people resort to herb, fruit or musk aromas to disguise underarm odor. rarely, however, can a deodorant inhibit perspiration or retard bacterial growth and odor for more than a very brief time. what is an anti-perspirant? a true anti-perspirant, as its name implies, should - like certain dri ® - shrink and close off underarm pores to inhibit the flow of perspiration. the more effective the formulation, the more effective and longer lasting the anti-perspirant relief will be. generally an anti-perspirant is also a deodorant because it prevents perspiration which is the source of odor-causing bacteria. however, a deodorant is not an anti-perspirant. is it safe to close off underarm pores? yes. both underarms represent an area of only about 6 to 8 sq. in. nature simply and safely redistributes the perspiration around to the other 2,700± sq. in. of the bodyâs skin surface. for additional information about certain dri ® visit our website: www.certaindri.com
Package Label Principal Display Panel:
Certain dri roll-on (aluminum chloride) liquid label image
Further Questions:
Questions? call 1-844-923-7837