Label: CERTAIN DRI ROLL-ON- aluminum chloride liquid

  • NDC Code(s): 69693-715-01, 69693-715-12, 69693-715-20
  • Packager: Clarion Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 2, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredientPurpose
    Aluminum Chloride 12.0%Antiperspirant
  • Uses

    • extra effective at reducing underarm perspiration
  • Warnings

    For external use only

  • DO NOT USE

    Do not use:

    • immediately after shaving

    • on broken skin

    • on irritated skin

    • immediately after bathing

  • When using this product

    • do not use in or near eyes

    • apply to underarms only

  • STOP USE

    Stop use and ask a doctor if rash or irritation develops

  • 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 only

    • apply at bedtime, see package insert

    • apply sparingly

    • apply only a few strokes under each arm

  • INACTIVE INGREDIENT

    Inactive ingredientspolyacrylate crosspolymer-6, sodium hydroxide, water

  • QUESTIONS

    Questions? Call 1-844-923-7837

  • 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 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.

    DIRECTIONS

    1. Apply 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.
    2. 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)
    3. 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 “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

  • PRINCIPAL DISPLAY PANEL

    NEW LOOK!

    CERTAIN DRI®
    PRESCRIPTION STRENGTH
    CLINICAL


    #1 Doctor recommended*

    Most effective antiperspirant you can buy without a prescription

    Up to 72 hour protection

    Antiperspirant
    ROLL-ON


    2.0 FL OZ (59.15 ml)

    Certain Dri® Prescription Strength Clinical helps stop excessive sweating for up to 72 hours.

    When is 12 more than 20?
    When it's the 12% Aluminum Chloride in Certain Dri® Prescription Strength Clinical.

    Other brands have aluminum complexes at higher percentages - but they are not the same!

    Aluminum Chloride is the strongest and most effective active ingredient available in antiperspirants and is the same active ingredient in may prescription formulations.

    Aluminum Chloride is the #1 Doctor recommended active ingredient for excessive sweating* and is why Certain Dri® Prescription Strength Clinical is different from the rest.

    Learn more at:
    www.certaindri.com

    * Based on a 2015 independent study, Certain Dri® is the #1 doctor recommended brand with the #1 doctor recommended ingredient for excessive sweating.

    Who is Certain Dri® Prescription Strength Clinical for?

    Anyone suffering from hyperhidrosis or excessive sweating looking for the strongest protection available without a prescription.

    Directions: For maximum protection and efficacy, apply Certain Dri® to each underarm before bed. Certain Dri® Prescription Strength Clinical works while you sleep, to stop sweating before it starts. To reduce the risk of irritation, be sure underarms are completely dry before applying.

    Satisfaction Guaranteed.

    If you are not completely satisfied, we will replace or refund your purchase.

    If you have any questions visit www.certaindri.com or call 1-844-923-7837

    Distributed by:
    Clarion Brands, LLC
    27070 Miles Road, Suite A
    Solon, OH 44139

    ©2016   7201

    Certain Dri® Prescription Strength Clinical helps stop excessive sweating for up to 72 hours.

    2 OZ CERTAIN DRI ROLL-ON Carton

    CERTAIN DRI®
    PRESCRIPTION
    STRENGTH
    CLINICAL


    #1 Doctor recommended*

    Antiperspirant
    ROLL-ON


    2.0 FL OZ (59.15 ml)

    Distributed by: Clarion Brands, LLC 27070 Miles Road,
    Suite A, Solon, OH 44139   ©2016

    7203

    2 OZ. CERTAIN DRI ROLL-ON Label

    NEW LOOK!

    CERTAIN DRI®
    PRESCRIPTION STRENGTH
    CLINICAL


    #1 Doctor recommended*

    Most effective antiperspirant you can buy without a prescription

    Up to 72 hour protection

    Antiperspirant
    ROLL-ON


    1.2 FL OZ (35.5 ml)

    Certain Dri® Prescription Strength Clinical helps stop excessive sweating for up to 72 hours.

    When is 12 more than 20?
    When it's the 12% Aluminum Chloride in Certain Dri® Prescription Strength Clinical.

    Other brands have aluminum complexes at higher percentages - but they are not the same!

    Aluminum Chloride is the strongest and most effective active ingredient available in antiperspirants and is the same active ingredient in may prescription formulations.

    Aluminum Chloride is the #1 Doctor recommended active ingredient for excessive sweating* and is why Certain Dri® Prescription Strength Clinical is different from the rest.

    Learn more at:
    www.certaindri.com

    * Based on a 2015 independent study, Certain Dri® is the #1 doctor recommended brand with the #1 doctor recommended ingredient for excessive sweating.

    Who is Certain Dri® Prescription Strength Clinical for?

    Anyone suffering from hyperhidrosis or excessive sweating looking for the strongest protection available without a prescription.

    Directions: For maximum protection and efficacy, apply Certain Dri® to each underarm before bed. Certain Dri® Prescription Strength Clinical works while you sleep, to stop sweating before it starts. To reduce the risk of irritation, be sure underarms are completely dry before applying.

    Satisfaction Guaranteed.

    If you are not completely satisfied, we will replace or refund your purchase.

    If you have any questions visit www.certaindri.com or call 1-844-923-7837

    Distributed by:
    Clarion Brands, LLC
    27070 Miles Road, Suite A
    Solon, OH 44139

    ©2016   7221

    Certain Dri® Prescription Strength Clinical helps stop excessive sweating for up to 72 hours.

    1.2 OZ CERTAIN DRI ROLL-ON Carton

    CERTAIN DRI®
    PRESCRIPTION
    STRENGTH
    CLINICAL


    #1 Doctor recommended*

    Antiperspirant
    ROLL-ON


    1.2 FL OZ (35.5 ml)

    Distributed by: Clarion Brands, LLC 27070 Miles Road,
    Suite A, Solon, OH 44139   ©2016

    7206

    1.2 OZ. CERTAIN DRI ROLL-ON Label

    TEAR HERE

    CERTAIN DRI®
    PRESCRIPTION STRENGTH
    CLINICAL

    #1 Doctor recommended
    Most effective antiperspirant you can buy without a prescription

    Antiperspirant TRIAL PAD

    Available in a Roll-on Bottle

    1 Pad - 1.3 ml per Pad

    Distributed by Clarion Brands, LLC
    27070 Miles Road, Suite A
    Solon, OH 44139

    500008

    www.certaindri.com

    Directions
    ■ apply to underarms only
    ■ use one pad to apply to both underarms
    ■ apply only a few strokes under each arm
    ■ use at night for best results

    SAMPLE

    CERTAIN DRI®
    ANTI-PERSPIRANT

    Directions for Use

    Important Facts About Perspiration Problems

    The Certain Dri Protection System™

    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 SOLID Insert
  • INGREDIENTS AND APPEARANCE
    CERTAIN DRI  ROLL-ON
    aluminum chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69693-715
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Chloride (UNII: 3CYT62D3GA) (Aluminum Cation - UNII:3XHB1D032B) Aluminum Chloride0.12 mg  in 1.0 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69693-715-121 in 1 CARTON11/01/2015
    135.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:69693-715-201 in 1 CARTON11/01/2015
    22.0 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    3NDC:69693-715-011 in 1 POUCH04/01/2016
    31.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35011/01/2015
    Labeler - Clarion Brands, LLC (079742703)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROCESS TECHNOLOGIES AND PACKAGING, INC.809172885manufacture(69693-715)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(69693-715)
    Establishment
    NameAddressID/FEIBusiness Operations
    Span Packaging Services LLC557434805manufacture(69693-715)