ANTI-PERSPIRANT DEODORANT- aluminium zirconium tetrachlorohydrex gly liquid
Xtreme Tools International, Inc

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.

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ANTI-PERSPIRANT DEODORANT

Active Ingredient

Aluminium Zirconium Tetrachlorohydrex Gly (15%)

Purpose

Antiperspirant

Use

Reduces underarm wetness

Warnings

For external use only.

Do not use on broken skin.

Stop use and Ask Doctor if rash or 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 Poison Control Center right away.

Directions

Apply to underarms only.

Inactive Ingredients

Brassica Glycerides, Polyester-4, C 13-16 lsoparaffin, Heptyl Undecylenate, Cyclotetrasiloxane. Caprylic/Capric Triglyceride, PPG-14 Butyl Ether, Stearyl Alcohol, Fragrance

Questions or comments?

Call 1-305-622-7474 Monday through Friday 9:00 AM to 5:00 PM

Principal Display Panel

59 mL in Bottle; NDC 74553-001-01

Deo

ANTI-PERSPIRANT DEODORANT
aluminium zirconium tetrachlorohydrex gly liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74553-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	15 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 4 (UNII: CZ227117JE)
TRICAPRIN (UNII: O1PB8EU98M)
PPG-14 BUTYL ETHER (UNII: R199TJT95T)
POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL) (UNII: 571593769G)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
BRASSICA JUNCEA SEED OIL (UNII: 4D13WHP5F7)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74553-001-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	10/06/2020

Labeler - Xtreme Tools International, Inc (125398904)

Registrant - Xtreme Tools International, Inc (125398904)

Name	Address	ID/FEI	Business Operations
Establishment
Xtreme Tools International, Inc		125398904	manufacture(74553-001)