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NDC 76118-0003-01 PURAX 15 mg/mL Details

PURAX 15 mg/mL

PURAX is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Purax International GmbH. The primary component is ALUMINUM CHLORIDE.

Product Information

NDC	76118-0003
Product ID	76118-0003_7b96d467-73e3-5ffc-e053-2991aa0a10c6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PURAX
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aluminum Chloride Hexahydrate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	15
Active Ingredient Units	mg/mL
Substance Name	ALUMINUM CHLORIDE
Labeler Name	Purax International GmbH
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part350
Listing Certified Through	n/a

Package

Package Images

NDC 76118-0003-01 (76118000301)

Pricing Information	N/A
NDC Package Code	76118-0003-1
Billing NDC	76118000301
Package	50 mL in 1 BOTTLE, WITH APPLICATOR (76118-0003-1)
Marketing Start Date	2014-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1f6ee1db-aedd-4f20-ab21-b23a8be93f28 Details

Active ingredient

ALUMINUM CHLORIDE HEXAHYDRATE 15%

Purpose

Antiperspirant

Uses

Reduces underarm perspiration

Warnings

For external use only

Do not use

on broken skin or face

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 right away.

Directions

Apply once a week to clean underarms before going to bed. Apply to underarms only.

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Aloe Barbadensis Gel, Glycerin, Cetyl Palmitate, Ceteareth-20, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-12, Fregrance, Tocopheryl Acetate, Ethylhexylglycerin Citric Acid, Sodium Benzoate, Potassium Sorbate, BHT

Questions?

Sweat Solutions LLC

1309 S. Flower St.

Burbank, CA 92502

Principal Display Panel

Purax

Pure Pads

Unisex

Antiperspirant Deodorant

Roll On

Clinical Strength

Manufactured for PURAX by

Schrofner Cosmetics

Robinigstrate Be 26a

5020 Salzburg, Austria

LOT/EXP: See Bottom

Made in Austria, EU

INGREDIENTS AND APPEARANCE

PURAX

aluminum chloride hexahydrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76118-0003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM CHLORIDE (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM CHLORIDE	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALOE (UNII: V5VD430YW9)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARETH-12 (UNII: 7V4MR24V5P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76118-0003-1	50 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/17/2014	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	02/17/2014	12/31/2023

Labeler - Purax International GmbH (300029336)

Name	Address	ID/FEI	Business Operations
Establishment
Schrofner Cosmetics Gmbh		300226873	manufacture(76118-0003)

Revised: 11/2018

Document Id: 7b96d467-73e3-5ffc-e053-2991aa0a10c6

Set id: 1f6ee1db-aedd-4f20-ab21-b23a8be93f28

Version: 2

Effective Time: 20181126