CERTAIN DRI ROLL-ON- aluminum chloride liquid

CERTAIN DRI by

Drug Labeling and Warnings

CERTAIN DRI by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

• Active ingredient: Purpose
• 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

CERTAIN DRI ROLL-ON (ALUMINUM CHLORIDE) LIQUID

INGREDIENTS AND APPEARANCE

CERTAIN DRI  ROLL-ON
aluminum chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-0122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM CHLORIDE (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM CHLORIDE	0.12 mg  in 1.0 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Hydroxide (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-0122-07	1 in 1 CARTON	01/01/2017
1		35.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 0295-0122-12	1 in 1 CARTON	01/01/2017
2		59.15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part350	01/01/2017

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-0122)