NDC 0295-0122 Certain Dri Roll-on

Aluminum Chloride

NDC Product Information

Certain Dri Roll-on with NDC 0295-0122 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc.. The generic name of Certain Dri Roll-on is aluminum chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Denison Pharmaceuticals, Llc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Certain Dri Roll-on Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALUMINUM CHLORIDE .12 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Denison Pharmaceuticals, Llc.
Labeler Code: 0295
FDA Application Number: part350 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 01-01-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Certain Dri Roll-on Product Label Images

Certain Dri Roll-on Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Purpose

Active ingredientPurposeAluminum Chloride 12.0%Antiperspirant

Uses

  • Extra effective at reducing underarm perspiration

Warnings

For external use only

Otc - Do Not Use

  • Do not use:immediately after shavingon broken skinon irritated skinimmediately after bathing

When Using This Product

  • Do not use in or near eyesapply to underarms only

Otc - Stop Use

Stop use and ask a doctor if rash or irritation develops

Otc - Ask Doctor

Ask a doctor before use if you have kidney disease

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Apply to underarms onlyapply at bedtime, see package insertapply sparinglyapply only a few strokes under each arm

Inactive Ingredient

Inactive ingredientspolyacrylate crosspolymer-6, sodium hydroxide, water

Otc - Questions

Questions? Call 1-844-923-7837

Package Insert

  • CERTAIN DRI® ANTI-PERSPIRANT Directions for UseImportant Facts About Perspiration ProblemsThe Certain Dri Protection™ SystemCERTAIN DRI®Clarion Brands, LLC27070 Miles Road, Suite ASolon, OH 44139Toll-Free 1-844-923-7837Certain Dri® is a registered trademark of Clarion Brands, LLCAB1002CERTAIN DRI® ANTI-PERSPIRANT...THE MOST EFFECTIVE ANTI-PERSPIRANT YOU CAN BUYWITHOUT 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 ingredients, 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. DIRECTIONSApply Clinical Strength Certain Dri® anti-perspirant to underarms at bedtime. That’s 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 SolidIn the morning for all day freshness and deodorant protections, use Everyday Strength Certain Dri® A.M.FACTS ABOUT PERSPIRATION PROBLEMSWhat 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 “overheats” 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 body’s skin surface. For additional information about Certain Dri® visit our website: www.certaindri.com

* Please review the disclaimer below.