STEFANO ROYAL- aluminum chlorohydrate liquid

STEFANO ROYAL by

Drug Labeling and Warnings

STEFANO ROYAL by is a Otc medication manufactured, distributed, or labeled by TERESA CECENA DBA GENESIS, TERESA CECENA, MISSION HILLS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Aluminium chlorhydrate

PURPOSE

PURPOSE:

Antiperspirant

KEEP OUT OF REACH OF CHILDREN

KEEP OUT THE REACH OF CHILDREN

DOSAGE & ADMINISTRATION

USE:

Reduces underarm persperation

FOR EXTERNAL USE ONLY

WARNINGS AND PRECAUTIONS

DIRECTION

APPLY UNDER ARM ONLY

SHAKE WELL BEFORE USE

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

INACTIVE INGREDIENT

WATER, SOY OIL, STEARTH2, PPG-15 STEARYL ETHER, STEARETH-20,FRAGANCE, CAPRYLYGLYCOL, TETRASODIUM, AND BHT

INDICATIONS & USAGE

APPLY UNDER ARM

WARNINGS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STEFANO ROYAL 
aluminum chlorohydrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-050
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 50 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: 69772-050-01	50 mL in 1 APPLICATOR; Type 0: Not a Combination Product	01/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part350	01/29/2016

Labeler - TERESA CECENA DBA GENESIS (078760958)

Registrant - TERESA CECENA (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
TERESA CECENA DBA GENESIS		078760958	relabel(69772-050)

Establishment
Name	Address	ID/FEI	Business Operations
MISSION HILLS		812312122	manufacture(69772-050)