LAB SERIES SKIN SUPPLIES FOR MEN ANTIPERSPIRANT DEODORANT- aluminum zirconium tetrachlorohydrex gly stick

LAB SERIES SKIN SUPPLIES FOR MEN ANTIPERSPIRANT DEODORANT by

Drug Labeling and Warnings

LAB SERIES SKIN SUPPLIES FOR MEN ANTIPERSPIRANT DEODORANT by is a Otc medication manufactured, distributed, or labeled by Aramis Inc., Estee Lauder Companies Inc., KDC/ONE SWALLOWFIELD LIMITED, WHITMAN LABORATORIES, LTD., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER N.V, LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Aluminum Zirconium
Tetrachlorohydrex Gly 18.6%

Purpose

Antiperspirant

Use

• Decreases underarm perspiration.

Warnings

For external use only.

Do not apply to broken skin. If irritation develops, discontinue use. For underarm use only. 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.

Inactive Ingredients

CYCLOPENTASILOXANE ∙ STEARYL ALCOHOL ∙ TALC ∙ PPG-14 BUTYL ETHER ∙ HYDROGENATED CASTOR OIL ∙ GLYCERYL HYDROXYSTEARATE ∙ ARACHIDYL ALCOHOL <ILN41646>

PRINCIPAL DISPLAY PANEL - 75 ml Bottle Label

LAB
SERIES
SKINCARE FOR MEN

ANTIPERSPIRANT
DEODORANT
STICK

Stick Déodorant
Antiperspirant

BODY

NET WT. 2.6 OZ./75 ml e

INGREDIENTS AND APPEARANCE

LAB SERIES SKIN SUPPLIES FOR MEN ANTIPERSPIRANT DEODORANT 
aluminum zirconium tetrachlorohydrex gly stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42472-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	18.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
cyclomethicone 5 (UNII: 0THT5PCI0R)
stearyl alcohol (UNII: 2KR89I4H1Y)
talc (UNII: 7SEV7J4R1U)
ppg-14 butyl ether (UNII: R199TJT95T)
hydrogenated castor oil (UNII: ZF94AP8MEY)
arachidyl alcohol (UNII: 1QR1QRA9BU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42472-004-01	1 in 1 CARTON	07/01/2015
1		75 mL in 1 CYLINDER; 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	07/01/2015

Labeler - ARAMIS INC. (042918826)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(42472-004) , REPACK(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(42472-004) , REPACK(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(42472-004) , REPACK(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(42472-004)

Establishment
Name	Address	ID/FEI	Business Operations
Swallowfield PLC		296491541	MANUFACTURE(42472-004)