MedPath
FDA Approval

MELAO Whitening Antiperspirant Deodorant Stick (rose)

May 26, 2025

HUMAN OTC DRUG LABEL

Manufacturing Establishments (1)

Guangzhou Haishi Biological Technology Co., Ltd.

Guangzhou Haishi Biological Technology Co., Ltd.

421262738

Products (1)

MELAO Whitening Antiperspirant Deodorant Stick (rose)

60771-0014

M019

OTC Monograph Drug (C200263)

TOPICAL

May 26, 2025

CETEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
ASCORBYL TETRAISOPALMITATEInactive
Code: 47143LT58AClass: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4Class: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8Class: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309Class: IACT
Code: 8O386558JEClass: ACTIBQuantity: 15.5 g in 100 g
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7UClass: IACT
SORBITAN STEARATEInactive
Code: NVZ4I0H58XClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label


INDICATIONS & USAGE SECTION

DIRECTION:Spin out the paste, apply evenly under thearmpit.

DOSAGE & ADMINISTRATION SECTION

Use regularly every day for the first 1week of use and every 3-5 days thereafter as needed.


WARNINGS SECTION

Ask a doctor before use if you have kidney disease.

if swallowed, get medical help or contact a Poison Control Center right away.


OTC - ACTIVE INGREDIENT SECTION

ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.5%

OTC - PURPOSE SECTION

Antiperspirant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - DO NOT USE SECTION

Do not use on broken skin.

OTC - STOP USE SECTION

Stop use if rash or irritation occurs.

OTC - WHEN USING SECTION

Dry first before putting on clothes.Make sure your armpits are clean, dry,and not iniured or recently shaved.Clean the armpits the next day.Thereare no restrictions if you want to use perfume or other deodorants.keep out of eyes.


INACTIVE INGREDIENT SECTION

OZOKERITE10%
CETEARYL ALCOHOL4%
BUTYROSPERMUM PARKII (SHEA BUTTER)18%
CAPRYLIC/CAPRIC TRIGLYCERIDE10%
ETHYLHEXYL PALMITATE24.8%
GLYCERYL STEARATE4%
SORBITAN STEARATE4%
CERA ALBA6%
ASCORBIC ACID0.5%
TOCOPHEROL1%
ASCORBYL TETRAISOPALMITATE0.2%
PARFUM2%


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