Helmm Antiperspirant and Deodorant

HELMM ANTIPERSPIRANT DEODORANT TRAILBLAZER- aluminum zirconium tetrachlorohydrex gly gel
ZGTL, LLC

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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Helmm Antiperspirant and Deodorant - Trailblazer

Aluminum Zirconium Tetrachlorohydren GLY (18%)

Cyclopentasiloxane, Stearyl Alcohol, PPG-14 Butyl Ether, Cetyl Alcohol, C12-C15 Alkyl Benzoate, Dimethicone 10 CST, Hydrogenated Castor Oil, Behenyl Alcohol, Sunflower Seed Oil, Vegetable Glycerin, Tapioca Starch, Steareth-2, Corn Starch, Fragrance, Vitamin E Acetate, Aloe Leaf Extract

Uses: reduces underarm wetness

Warnings
For external use only
Do not use on broken skin
Ask a doctor before use if you have kidney disease
Stop use if rash or irritation occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses: reduces underarm wetness

Trailblazer

HELMM ANTIPERSPIRANT DEODORANT TRAILBLAZER
aluminum zirconium tetrachlorohydrex gly gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72147-1803
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	18 g in 57 g

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
PPG-14 BUTYL ETHER (UNII: R199TJT95T)
STARCH, TAPIOCA (UNII: 24SC3U704I)
STEARETH-2 (UNII: V56DFE46J5)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)
DOCOSANOL (UNII: 9G1OE216XY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE 20 (UNII: H8YMB5QY0D)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72147-1803-1	71 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	04/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	04/10/2018

Labeler - ZGTL, LLC (081049362)

Registrant - ZGTL, LLC (081049362)

Name	Address	ID/FEI	Business Operations
Establishment
Raining Rose		083819404	manufacture(72147-1803) , api manufacture(72147-1803)