ANTIPERSPIRANT DRY 2 OZ LADY- aluminum chlorohydrate aerosol, spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)
Available from:
Rejoice International Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiperspirant Reduces underarm wetness
Authorization status:
OTC monograph final
Authorization number:
57337-103-01

ANTIPERSPIRANT DRY 2 OZ LADY- aluminum chlorohydrate aerosol, spray

Rejoice 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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Antiperspirant Dry 2 oz Lady

Active Ingredient ........................................................................... Purpose

Aluminum Chlorohydrate 23.3% .................................................. Antiperspirant

Antiperspirant

Keep out of reach of children.

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

immediately. Do not use on children under 2 years of age unless directed by a doctor.

Reduces underarm wetness

Warnings

For external use only.

Flammable.

Do not use while smoking or near heat or flame or while smoking. Can cause serious

injury or death.

Keep away from face and mouth to avoid breathing in.

Avoid spraying in eyes. CONTENTS UNDER PRESSURE. Do not puncture or incinerate. Do not

expose to heat or store at temperatures above 120

F/50

C or in enclosed places that could

overheat.

Do not use on broken or irrated skin. Stop use if rash or irritation develops.

Ask a doctor before using, if you have kidney disease.

KEEP OUT OF REACH OF CHILDREN.

USE ONLY AS DIRECTED. INTENTIONAL MISSUSE BY DELIBERATELY

CONCENTRATING AND INHAILING THE CONTENTS CAN BE HARMFUL OR FATAL.

Help stop inhalation abuse. For more information visit www.inhalant.org

Directions

For underarm use only. Shake can well before each use. Hold can 6 inches away from skin. Spray

underarm.

Inactive Ingredients

Isobutane, Butane, Hydrofluorocarbon 152a, Cyclopentasiloxane, Ethyl Alcohol, PPG-14 Butyl Ether,

Helianthus Annuus Seed Oil, Isopropryl Myristate, C12-15 Alkyl Benzoate, Frangrance, Propane,

Aluminum Starch Ocetenylsuccinate, Disteardimonium Hectorite, Dimethicone, Tocopheryl Acetate,

BHT, Silica

ANTIPERSPIRANT DRY 2 OZ LADY

aluminum chlorohydrate aerosol, spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:57337-10 3

Route of Administration

TOPICAL

Rejoice International Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALUMINUM CHLO RO HYDRATE (UNII: HPN8 MZW13M) (ALUMINUM CHLOROHYDRATE -

UNII:HPN8 MZW13M)

ALUMINUM

CHLOROHYDRATE

23.3 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

ALUMINUM STARCH O CTENYLSUCCINATE (UNII: I9 PJ0 O6 29 4)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

PPG-14 BUTYL ETHER (UNII: R19 9 TJT9 5T)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

ISO BUTANE (UNII: BXR49 TP6 11)

1,1-DIFLUO RO ETHANE (UNII: 0 B1U8 K2ME0 )

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

PRO PANE (UNII: T75W9 9 11L6 )

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:57337-10 3-

56 .7 g in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/22/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt350

0 4/22/20 19

Labeler -

Rejoice International Inc. (078741245)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Wuxi Huo ban Daily-Use Chemicals Science and Techno lo gy Co ., Ltd.

42120 7374

ma nufa c ture (57337-10 3)

Revised: 4/2019

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