STEFANO GLADIUS ROLL-ON- aluminum chlorohydrate liquid

Stefano Gladius by

Drug Labeling and Warnings

Stefano Gladius by is a Otc medication manufactured, distributed, or labeled by Teresa Cecena DBA Genesis, Teresa, Colgate Palmolive S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Aluminum Chlorohydrate

PURPOSE

Purpose:

Antiperspirant

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

DOSAGE & ADMINISTRATION

USE:

Reduces underarm persperation

WARNINGS

FOR EXTERNAL USE ONLY

INDICATIONS & USAGE

DIRECTIONS

APPLY UNDER ARM ONLY

SHAKE WELL BEFORE USE

WARNINGS AND PRECAUTIONS

DO NOT APPLY ON IRRITATED OR INJURED SKIN. DISCONTINUE USE IF YOU EXPERIENCE SOME IRRITATION, REDNESS OR DISCOMFORT

INACTIVE INGREDIENT

WATER, SOYOIL, STEARTH-2, PPG-15 STEARYL ETHER, STEARETH-20, FRAGANCE, CAPRYLY GLYCOL. TETRASOSIUM EDTA, AND BHT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STEFANO GLADIUS  ROLL-ON
aluminum chlorohydrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)	ALUMINUM CHLOROHYDRATE	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
STEARETH-2 (UNII: V56DFE46J5)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOSTEARETH-20 (UNII: 78H2SJ8X8M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-040-01	50 mL in 1 APPLICATOR; Type 0: Not a Combination Product	06/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part350	06/02/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
Teresa Cecena DBA Genesis		078760958	relabel(69772-040)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate Palmolive S.A. de C.V.		810007526	manufacture(69772-040)