STEFANO STICK- aluminium chlorohydrate stick
Teresa Cecena DBA Genesis

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ACTIVE INGREDIENT:

ALUMINUM CHLOROHYDRATE

PURPOSE

Antitraspirant

KEEP OUT OF THE REACH OF CHILDREN

WARNINGS:

For external use only. Do not apply on irritated or injured skin. Discontinue use if you experience some irritation, redness or discomfort.

Directions:

Apply under arm only.

SHAKE WELL BEFORE USE.

Water, soy oil, stearth-2, PPG-15 stearyl ether, steareth-20, fragance, caprylyl glycol, tetrasodium edta, and bht

Stefano Black

SHAKE WELL BEFORE USE

Apply under arm only

STEFANO STICK
aluminium chlorohydrate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69772-900
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
STEARETH-20 (UNII: L0Q8IK9E08)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARETH-2 (UNII: V56DFE46J5)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE SODIUM (UNII: MP1J8420LU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69772-900-64	50 mL in 1 APPLICATOR; Type 0: Not a Combination Product	05/18/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	05/18/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa Cecena (078760958)

Name	Address	ID/FEI	Business Operations
Establishment
Teresa Cecena DBA Genesis		078760958	relabel(69772-900)

Name	Address	ID/FEI	Business Operations
Establishment
Colgate Palmolive S.A. De C.V.		810007526	manufacture(69772-900)

Revised: 5/2015

Document Id: 165dfeb4-8192-4e5a-e054-00144ff88e88

Set id: 165dfeb4-8191-4e5a-e054-00144ff88e88

Version: 1

Effective Time: 20150518

Teresa Cecena DBA Genesis