MedPath
FDA Approval

MELAO Discoloration Correcting Antiperspirant Deodorant Stick (fresh floral)

May 27, 2025

HUMAN OTC DRUG LABEL

Manufacturing Establishments (1)

Guangzhou Haishi Biological Technology Co., Ltd.

Guangzhou Haishi Biological Technology Co., Ltd.

421262738

Products (1)

MELAO Discoloration Correcting Antiperspirant Deodorant Stick (fresh floral)

60771-0017

M019

OTC Monograph Drug (C200263)

TOPICAL

May 27, 2025

ETHYLHEXYL PALMITATEInactive
Code: 2865993309Class: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
Code: 8O386558JEClass: ACTIBQuantity: 11.5 g in 100 g
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7UClass: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4Class: IACT
SORBITAN STEARATEInactive
Code: NVZ4I0H58XClass: IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OILInactive
Code: 3W1JG795YIClass: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4Class: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label


INDICATIONS & USAGE SECTION

STEP1: Clean and thoroughly dry your skin.

STEP2: Twist the bottom of the product.

STEP3: Gently apply to the underarms or other desired areas.

DOSAGE & ADMINISTRATION SECTION

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


WARNINGS SECTION

For external use only.

Ask a doctor before use if you havekidney disease.

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


OTC - ACTIVE INGREDIENT SECTION

ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY11.5%

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 useperfume or other deodorants


INACTIVE INGREDIENT SECTION

OZOKERITE10%
CETEARYL ALCOHOL4%
BUTYROSPERMUM PARKII(SHEA)BUTTER15%
CAPRYLIC/CAPRIC TRIGLYCERIDE12%
ETHYLHEXYL PALMITATE27.5%
GLYCERYL STEARATE4%
SORBITAN STEARATE4%
CERA ALBA6%
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL1%
NIACINAMIDE3%
PARFUM2%


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