SURE ORIGINAL SOLID FRESH AND COOL- aluminum zirconium tricholorohydrex gly stick

Sure Original Solid Fresh and Cool by

Drug Labeling and Warnings

Sure Original Solid Fresh and Cool by is a Otc medication manufactured, distributed, or labeled by Idelle Labs, Ltd, KDC/ONE Development Corporation, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SURe®
48 hr CONFIDENCE
FRESH & COOL
original solid
ANTI-PERSPIRANT & DEODORANT
Net Wt 2.7oz (76g)

Drug Facts

Active ingredient

Aluminum Zirconium Trichlorohydrex GLY 16% (anhydrous)

Purpose

Antiperspirant

Use

Reduces underarm wetness

Warnings

For external use only.

Do not use

On broken skin

Ask a doctor before use if you have

Kidney disease

Stop use if

Rash or irritation occurs

Keep out of reach of children.

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

Directions

Apply to underarms only

Inactive ingredients

Cyclopentasiloxane, Stearyl Alcohol, Talc, Dimethicone, Hydrogenated Castor Oil, Fragrance, Polyethylene, Silica, Dipropylene Glycol, Behenyl Alcohol.

Questions?

1 800 487-7273
www.suredeodorant.com

© Idelle Labs, Ltd. All rights reserved.
Made in CANADA. Distributed by Idelle Labs, Ltd.,
El Paso, TX 79912 USA
Sure® is a trademark of Kaz Europe Sarl.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SURE ORIGINAL SOLID FRESH AND COOL 
aluminum zirconium tricholorohydrex gly stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41595-5546
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY (UNII: T27D6T99LH) (ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY - UNII:T27D6T99LH)	ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY	16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DOCOSANOL (UNII: 9G1OE216XY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41595-5546-1	76 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	01/01/2015

Labeler - Idelle Labs, Ltd (128822926)

Registrant - Idelle Labs, Ltd (128822926)

Establishment
Name	Address	ID/FEI	Business Operations
Les Emballages Knowlton, Inc.		248704645	MANUFACTURE(41595-5546)