ANTIPERSPIRANT-DEODORANT ROLL-ON- aluminum chlorohydrate liquid

ANTIPERSPIRANT-DEODORANT ROLL-ON by

Drug Labeling and Warnings

ANTIPERSPIRANT-DEODORANT ROLL-ON by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Aluminum chlorohydrate 18.20%

Purpose

Antiperspirant

Use

Reduces underarm wetness

Warnings

For external use only

Do not use on broken skin

Stop use if irritation occurs

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

water\aqua\eau ceteth-2 ppg-11 stearyl ether steareth-20 myristalkonium chloride quaternium-14 sorbic acid trisodium edta [iln37802]

PRINCIPAL DISPLAY PANEL - 75 ml Bottle Label

C
CLINIQUE

antiperspirant-
deodorant
roll-on

ALUMINUM CHLOROHYDRATE

2.5 FL.OZ.LIQ./75 ml e

INGREDIENTS AND APPEARANCE

ANTIPERSPIRANT-DEODORANT ROLL-ON 
aluminum chlorohydrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aluminum chlorohydrate (UNII: HPN8MZW13M) (Aluminum chlorohydrate - UNII:HPN8MZW13M)	Aluminum chlorohydrate	211 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ceteth-2 (UNII: 7H8VAM7778)
ppg-11 stearyl ether (UNII: S4G2J0Y0LG)
steareth-20 (UNII: L0Q8IK9E08)
myristalkonium chloride (UNII: 0W255OL75T)
quaternium-14 (UNII: ZGE94G6AGI)
sorbic acid (UNII: X045WJ989B)
edetate trisodium (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-076-01	75 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	01/15/2020

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-076) , REPACK(49527-076)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-076)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-076)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-076)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-076)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-076) , REPACK(49527-076)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-076) , REPACK(49527-076)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-076)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-076)