DURADRY ANTIPERSPIRANT- 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.

----------

Duradry AM Deoderant & Antiperspirant Clear Sky

Active Ingredients

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.

Stop use

if rash or irritation occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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

Duradry AM Deoderant & Antiperspirant Clear Sky

Principle Display Label

DURADRY ANTIPERSPIRANT
aluminum zirconium trichlorohydrex gly stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0534
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY (UNII: T27D6T99LH) (ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY - UNII:T27D6T99LH)	ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY	199 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
C13-15 ALKANE (UNII: 114P5I43UJ)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)
SODIUM CAPROYL LACTYLATE (UNII: 87WR3BHC09)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SAGE OIL (UNII: U27K0H1H2O)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOHEXADECANE (UNII: 918X1OUF1E)

Product Characteristics
Color	white (White to Cream Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0534-3	65 mL in 1 CANISTER; Type 0: Not a Combination Product	02/02/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	02/02/2021

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(58443-0534) , label(58443-0534) , analysis(58443-0534) , pack(58443-0534)