Hypercare

aluminum chloride hexahydrate and alcohol

Dosage Form: solution
Hypercare® SOLUTION

Rx only

Hypercare SOLUTION is a solution of: Aluminum Chloride (Hexahydrate) 20% w/v in Anhydrous Ethyl Alcohol (S.D. Alcohol 40) 93% v/v.

INDICATION:

An aid in the management of hyperhidrosis.

DIRECTIONS:

Apply Hypercare to the affected area once a day, only at bedtime. To help prevent irritation, the area should be completely dry prior to application. Do not apply Hypercare to broken, irritated or recently shaved skin.

This product is not intended to be used as a roll-on. Turn the bottle upside-down and apply a small amount of pressure to release the solution into the Dab-O-Matic™ applicator. Then apply the Dab-O-Matic™ applicator to the affected areas.

CAUTION:

Do not apply excessive pressure on the bottle. Excessive pressure will cause the Dab-O-Matic™ applicator to become dislodged and the solution could spill. DO NOT APPLY AS A ROLL-ON.

FOR MAXIMUM EFFECT:

Your doctor may instruct you to cover the treated area with saran wrap held in place by a snug fitting "T" or body shirt, mitten or sock (never hold saran in place with tape). Wash the treated area the following morning. Excessive sweating may be stopped after two or more treatments. Thereafter, apply Hypercare once or twice weekly or as needed.

NOTICE:

Hypercare may produce a burning or prickling sensation. Keep cap tighly closed when not in use to prevent evaporation.

WARNING:

For external use only. Keep out of reach of children. Avoid contact with eyes. If irritation or sensitization occurs, discontinue use or consult with a physician. Hypercare may be harmful to certain metals and fabrics. Do not use near open flame.

PACKAGE:

37.5 cc polyethylene bottle.

NDC 58980-150-10.

35 cc bottle with Dab-O-Matic™ applicator.

NDC 58980-150-11.

60 cc bottle with Dab-O-Matic™ applicator.

NDC 58980-150-20.

INSTRUCTIONS FOR THE USE OF Hypercare

APPLICATION:

Dab-O-Matic™ Bottle – Apply Hypercare from the convenient applicator to the affected area.

Plastic Bottle – Moisten a cotton ball with Hypercare and apply to the affected area.

Apply once a day, only at bedtime. To help prevent irritation, the area should be completely dry prior to application. Do not apply Hypercare to broken, irritated or recently shaved skin.

FOR MAXIMUM EFFECT:

Your doctor may instruct you to cover the treated area with a saran wrap held in place by a snug fitting "T" or body shirt, mitten or sock (never hold saran in place with tape).

Wash the treated area the following morning.

Excessive sweating may be stopped after two or more treatments. Thereafter, apply Hypercare once or twice a week or as needed.

WARNING:

For external use only. Avoid contact with eyes. If irritation or sensitization occurs, discontinue use or consult with a physician. Keep out of the reach of children. Hypercare may be harmful to certain metals or fabrics. Keep away from open flame.

STORAGE:

Store between 15°-30°C (59°-86°F).

Manufactured by:

Sonar Products Inc.

Carlstadt, NJ 07072

Exclusively for:

Stratus Pharmaceuticals Inc.

14377 Southwest 142nd Street

Miami, Florida 33186-6727

Customer Service: 800-442-7882

Fax: 305-254-6875

Distributed by

STRATUS

PHARMACEUTICALS INC.

JG-HCSINS-20060213

RECOMMENDED APPLICATION PROCEDURES FOR:

HYPERHIDROSIS OF UNDERARMS (Axillae)

Apply Hypercare evenly to dry skin of underarms. To minimize irritation let the alcohol evaporate (if needed, blow dry with a hair dryer on a cold air setting) leaving an evenly distribution film of the antiperspirant on the skin. Wear a T-shirt while sleeping to prevent the medication from being rubbed off on bed linens. Do not apply Hypercare to broken, irritation or recently shaved skin. Now check instructions under "Next Morning".

HYPERHIDROSIS OF PALMS (Hands)

Apply Hypercare evenly to both palms, let the alcohol evaporate, leaving a thin film of antiperspirant on the skin. To keep the medication from being rubbed off during sleep, cover each hand with a sheet of saran wrap, held in place with a mitten or a cotton glove. (Do not use adhesive tape). Now check instructions under "Next Morning".

HYPERHIDROSIS OF FEET (Bromhidrosis)

Apply Hypercare evenly to both soles, let the alcohol evaporate, leaving a thin film of antiperspirant on the skin. To keep the medication from being rubbed off during sleep, cover each sole with a sheet of saran wrap, held in place with a sock. (Do not use adhesive tape). Now check the instructions under "Next Morning".

HYPERHIDROSIS OF THE SCALP

Apply Hypercare evenly to the scalp. Avoid contact with eyes. Let the alcohol evaporate, leaving a thin film of antiperspirant on the scalp. To keep the medication from being rubbed off during sleep, wear a plastic shower cap. Now check instructions under "Next Morning".

NEXT MORNING (Upon Arising)

Depending on the area being treated: Remove the T-shirt, gloves, socks or shower cap. Remove and discard saran wrap. Wash the treated area thoroughly with soap and water or shampoo, to remove the residual antiperspirant and to prevent skin irritation as well as damage to dry clothing, then towel dry the skin or scalp. Do not apply other deodorants or antiperspirants while using Hypercare. Following these procedures, repeat applications of Hypercare for 2 or 3 nights, until the desired ANHIDROSIS (lack of sweating) is achieved. Generally, after that, an application once or twice a week should maintain needed controlled protection from hyperhidrosis. Occasionally, there is some tingling or itching after application. Any irritation it might produce is temporary and will subside if application is avoided for a few days. Hypercare is not absorbed but works locally on outer skin.

Distributed by

STRATUS

PHARMACEUTICALS INC.

PRINCIPAL DISPLAY PANEL - 35 cc Carton

NDC 58980-150-11

Hypercare™

Hypercare

SOLUTION

is a solution

of: Aluminum

Chloride

(Hexahydrate)

20% w/v in

Anhydrous

Ethyl Alcohol

(S.D. Alcohol

40) 93% v/v.

Rx only

Distributed by:

STRATUS

NET WT 35 cc

Hypercare  aluminum chloride hexahydrate and alcohol  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58980-150 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM CHLORIDE HEXAHYDRATE (ALUMINUM CATION) ALUMINUM CHLORIDE HEXAHYDRATE 1 g  in 5 mL Alcohol (Alcohol) Alcohol 1.25 g  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58980-150-10 1 CYLINDER In 1 BOX contains a CYLINDER 1 37.5 mL In 1 CYLINDER This package is contained within the BOX (58980-150-10) 2 58980-150-11 1 CYLINDER In 1 BOX contains a CYLINDER 2 35 mL In 1 CYLINDER This package is contained within the BOX (58980-150-11) 3 58980-150-20 1 CYLINDER In 1 BOX contains a CYLINDER 3 60 mL In 1 CYLINDER This package is contained within the BOX (58980-150-20)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved other		12/07/2001

Labeler - Stratus Pharamceuticals, Inc (789001641)

Establishment
Name	Address	ID/FEI	Operations
Sonar Products, Inc		104283945	MANUFACTURE

Revised: 10/2009Stratus Pharamceuticals, Inc

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