MedPath

antibacterial body wash

85434-003 antibacterial body wash

Approved
Approval ID

3fff8d3e-1944-4813-e063-6294a90a1a1d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Guangdong Quaker Daily Chemical Co., LTD

DUNS: 548075342

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Silver

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85434-003
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Silver
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (11)

COCOS NUCIFERA (COCONUT) OILInactive
Code: Q9L0O73W7L
Classification: IACT
PEG-40 CASTOR OILInactive
Code: 4ERD2076EF
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MENTHA PIPERITA (PEPPERMINT) OILInactive
Code: AV092KU4JH
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SILVERActive
Quantity: 0.000132 g in 100 mL
Code: 3M4G523W1G
Classification: ACTIB
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT
EUCALYPTUS GLOBULUS LEAF OILInactive
Code: 2R04ONI662
Classification: IACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILInactive
Code: ZBP1YXW0H8
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

Helps reduce bacteria on the skin

For cleansing and refreshing the body

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Silver 0.000132%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Antibacterial

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/30/2025

Avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/30/2025

Stop use if irritation or rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/30/2025

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/30/2025

Apply body wash to wet skin
Work into a lather and rinse thorouahly
Use aaily as needed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
MENTHA PIPERITA (PEPPERMINT) OIL
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL
EUCALYPTUS GLOBULUS LEAF OIL
COCOS NUCIFERA (COCONUT) OIL
PEG-40 CASTOR OIL
GLYCERIN
MAGNESIUM CHLORIDE
PHENOXYETHANOL

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antibacterial body wash - FDA Drug Approval Details