DURADRY DEODORANT STICK- aluminum zirconium trichlorohydrex gly stick 
Prime Enterprises 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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Duradry AM Deodorant & Antiperspirant Limitless

Active Ingredient:

Aluminum Zirconium Trichlorohydrex Gly 20%

Purpose:

Antiperspirant.

Uses:

Reduces underarm perspiration.

Warnings:

For external use only.

Do not use on broken skin.

Ask a doctor before use if you have kidney disease.

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

Stop use if rash or irritation occurs.

Directions:

Apply to underarms only.

Inactive Ingredients:

C13-15 Alkane, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Palmitate, Ethylhexylglycerin, Fragrance, Hydrogenated Castor Oil, Isododecane, Isohexadecane, Maranta Arundinacea (Arrowroot) Root Extract, Salvia Officinalis (Sage) Oil, Sodium Caproyl/Lauroyl Lactylate, Stearyl Alcohol, Triethyl Citrate

Questions?

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Duradry AM Deodorant & Antiperspirant Limitless - 65 g

Principle Display Label

DURADRY  DEODORANT STICK
aluminum zirconium trichlorohydrex gly stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0428
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY (UNII: T27D6T99LH) (ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY - UNII:T27D6T99LH) ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
ISODODECANE (UNII: A8289P68Y2)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
C13-15 ALKANE (UNII: 114P5I43UJ)  
SAGE OIL (UNII: U27K0H1H2O)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0428-365 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35001/19/2021
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0428) , manufacture(58443-0428) , label(58443-0428) , analysis(58443-0428)

Revised: 9/2021
Document Id: cc32ebe1-13c4-7f2e-e053-2a95a90a6568
Set id: cc32ebd7-0b40-42e7-e053-2995a90a816a
Version: 1
Effective Time: 20210917
 
Prime Enterprises Inc.