ANTIPERSPIRANT ABOVE SOFT CREME- antiperspirant above soft creme aerosol aerosol, spray

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

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Active ingredient:
ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V)
Available from:
Baston Industria de Aerossóis Ltda
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final
Authorization number:
73306-1112-1

ANTIPERSPIRANT ABOVE SOFT CREME- antiperspirant above soft creme aerosol aerosol,

spray

Baston Industria de Aerossóis Ltda

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.

----------

Aluminum sesquichlorohydrate 24%

Antipers pirant

Uses - reduces underarm wetness

apply to underarms only

BUTANE/PROPANE/ ISOBUTANE /ALUMINUM SESQUICHLOROHYDRATE/

CYCLOPENTASILOXANE/DIMETHICONE/ISOPROPYL MYRISTATE/C12-15 ALKYL

BENZOATE/PARFUM/QUARTENIUM-18 HECTORITE/PROPYLENE

CARBONATE/CYCLOHEXASILOXANE/SILICA/TOCOPHERYL ACETATE/GOSSYPIUM

HERBACEUM SEED OIL/DIMETHICONE/VINYL DIMETHICONE

CROSSPOLYMER/GLYCINE SOJA OIL/ALLANTOIN/BUTYROSPERMUM PARKII

BUTTER/MACADAMIA TERNIFOLIA SEED OIL/

COCOS NUCIFERA FRUIT EXTRACT/CHAMOMILA RECUTITA FLOWER EXTRACT/

ALOE BARBADENSIS LEAF EXTRACT/CAMELLIA SINENSIS LEAF

EXTRACT/CINNAMOMUM ZEYLANICUM BARK EXTRACT/ACORUS CALAMUS ROOT

EXTRACT/COMMIPHORA MYRRHA RESIN EXTRACT/OLEA EUROPAEA FRUIT

OIL/PERSEA GRATISSIMA OIL/ARGANIA SPINOSA KERNEL OIL/LECITHIN/

POLYGLYCERYL-3 DIISOSTEARATE/GLYCERIN/GLYCERYL

STEARATE/CYCLOTETRASILOXANE/AQUA.

e-mail: sac @baston.com.br or call: +1(305)677-5030

Keep Out Of Reach Of Children

Flammable until fully dry. Do not use near heat, Flame or while smoking. Can cause serious

injury or deatKeep away from face and mouth to avoid breathing inAvoid spraying in

eyesContents under pressureDo not puncture or incinerateDo not expose to heat or store at

temperatures above 120 ºF/50 ºC or in enclosed places that could overheatDo not use on broken

skinStop use if rash or irritation occursAsk a doctor before using if you have kidney

diseaseUSE ONLY AS DIRECTEDINTENTIONAL MISUSE BY DELIBERATELY

CONCENTRATING AND INHALING THE CONTENTS CAN BE HARMFUL OR

FATALAvoid de inhalation of the product.

ANTIPERSPIRANT ABOVE SOFT CREME

antiperspirant above soft creme aerosol aerosol, spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7330 6 -1112

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALUMINUM SESQ UICHLO RO HYDRATE (UNII: UCN8 8 9 40 9 V) (ALUMINUM

SESQUICHLOROHYDRATE - UNII:UCN8 8 9 40 9 V)

ALUMINUM

SESQUICHLOROHYDRATE

24 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

GLYCERIN (UNII: PDC6 A3C0 OX)

LEVANT CO TTO N SEED (UNII: 550 E4N439 V)

PO LYGLYCERYL-3 DIISO STEARATE (UNII: 46 P231IQV8 )

CO CO NUT (UNII: 3RT3536 DHY)

ACO RUS CALAMUS RO O T (UNII: XY1K7KIQ0 F)

ALLANTO IN (UNII: 344S277G0 Z)

BUTANE (UNII: 6 LV4FOR43R)

CHAMO MILE (UNII: FGL36 8 5T2X)

ISO BUTANE (UNII: BXR49 TP6 11)

MACADAMIA O IL (UNII: 5156 10 SU8 C)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

VINYL DIMETHICO NE/METHICO NE SILSESQ UIO XANE CRO SSPO LYMER (UNII: 9 NH1UDD2RR)

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

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

AVO CADO O IL (UNII: 6 VNO72PFC1)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

CINNAMO N BARK O IL (UNII: XE54U56 9 EC)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

SHEA BUTTER (UNII: K49 155WL9 Y)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

MYRRH O IL (UNII: H74221J5J4)

PRO PANE (UNII: T75W9 9 11L6 )

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

ARGAN O IL (UNII: 4V59 G5UW9 X)

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

Product Characteristics

Color

yello w (Yello wish to yello w)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7330 6 -1112-1

9 0 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 9 /13/20 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 9 /13/20 19

Labeler -

Baston Industria de Aerossóis Ltda (897727605)

Registrant -

Baston Industria de Aerossóis Ltda (897727605)

Establishment

Baston Industria de Aerossóis Ltda

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Basto n Industria de Aero ssó is Ltda

8 9 77276 0 5

ma nufa c ture (7330 6 -1112)

Revised: 9/2019

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