Label: CERTAIN DRI ROLL-ON- aluminum chloride liquid 

  • NDC Code(s): 89411-1140-1
  • Packager: DSE Healthcare Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/12

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

  • Active ingredient

    Aluminum Chloride 12%

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  • Purpose

    Antiperspirant

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  • Uses

    • treats excessive perspiration
    • reduces underarm wetness
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  • Warnings

    For external use only

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  • Do not use

    • immediately after shaving

    • on broken skin

    • on irritated skin

    • immediately after bathing

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  • When using this product

    • do not use in or near eyes

    • apply to underarms only

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  • Stop use and ask a doctor if

    rash or irritation develops

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  • Ask a doctor before use if

    you have kidney disease

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  • Keep out of reach of children.

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

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  • Directions

    • apply to underarms only

    • apply only at bedtime, see package insert

    • apply sparingly

    • apply only a few strokes under each arm

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  • Inactive ingredients

    sodium bicarbonate, water

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  • Questions?

    Call 1-800-331-0221

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  • Directions for use

    CERTAIN DRI® ANTI-PERSPIRANT...
    THE MOST EFFECTIVE ANTI-PERSPIRANT YOU CAN BUY WITHOUT A PRESCRIPTION.

    Certain Dri® Roll-On contains Aluminum Chloride (AICI3), 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. 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, 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 Certain Dri® anti-perspirant to underarms at bedtime. That’s because 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, 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 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?

    Since Certain Dri® works best when used at bedtime, we have specially formulated Certain Dri AM just for morning and daytime use. It will provide the all day freshness and deodorant protection you need.

    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 CERTAIN DRI® Anti-Perspirant - Roll-On or Solid
    • In the morning for all day freshness and deodorant protections, use CERTAIN DRI A.M.™ Underarm Refresher.

    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.

    ARMY RESEARCHERS SAY USING ANTI-PERSPIRANT CAN PREVENT BLISTERS ON YOUR FEET

    According to US Army medical researchers; "Anti-perspirant reduces the sweating that creates friction, and friction leads to blisters. By reducing sweating, an antiperspirant also helps existing foot blisters to heal faster."

    Lead researcher, Joseph Knapik MD, suggests applying an anti-perspirant to your feet every day for five days before a major walk, run or bike ride.

    For additional information about Certain Dri® visit our website: www.certaindri.com

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  • PRINCIPAL DISPLAY PANEL

    Stops Excessive Perspiration for 72 Hours

    #1 Doctor Recommended

    CLINICAL STRENGTH

    CERTAIN DRI® ROLL-ON ANTI-PERSIPIRANT

    1.2 FL OZ (35.5 ml)

    THE MOST EFFECTIVE ANTI-PERSIPIRANT YOU CAN BUY WITHOUT A PRESCRIPTION

    ROLL-ON ACTUAL SIZE

    Guaranteed Satisfaction

    This product is guaranteed to give you superior anti-perspirant satisfaction when used as directed. If you are not completely satisfied, send the purchase receipt to the address on the box for a full refund.

    Certain Dri® contains Aluminum Chloride, the ingredient prescribed by Doctors to patients with excessive perspiration or Hyperhidrosis. Laboratory studies prove that Aluminum Chloride is more effective and longer lasting than other ingredients found in anti-perspirants, yet safe when used as directed.

    IMPORTANT: Apply only at bedtime. See package insert.

    Distributed by DSE Healthcare Solutions, LLC.
    Edison, NJ 08818 1(800)331-0221 1004 Rev. 9/11
    www.dsehealth.com

    CERTAIN DRI ROLL-ON Carton

    Stops Excessive Perspiration for 72 Hours

    #1 Doctor Recommended

    CLINICAL STRENGTH

    CERTAIN DRI®
    ROLL-ON
    ANTI-PERSIPIRANT


    1.2 FL OZ (35.5 ml)

    Distributed by DSE Healthcare Solutions, LLC. Edison, NJ 08818
    1-800-331-0221 Rev. 11/10 1009 www.dsehealth.com

    CERTAIN DRI ROLL-ON Label

    IMPORTANT
    Apply at Bedtime

    Sensitive Skin?
    Try the SOLID

    CERTAIN DRI ROLL-ON Cap Label
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  • INGREDIENTS AND APPEARANCE
    CERTAIN DRI  ROLL-ON
    aluminum chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:89411-1140
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aluminum Chloride (Aluminum Cation) Aluminum Chloride 12 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Bicarbonate  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:89411-1140-1 35.5 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part350 05/22/2012
    Labeler - DSE Healthcare Solutions, LLC (603016069)
    Establishment
    Name Address ID/FEI Business Operations
    San-Mar Laboratories, Inc. 078718053 MANUFACTURE(89411-1140)
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