MedPath

CharmTex All in One Antibacterial Shave Gel Body Wash

85420-003 All in One antibacterial shave body wash, shampoo

Approved
Approval ID

a7433f39-a8d9-4c78-864d-d7ef193a7daf

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 1, 2025

Manufacturers
FDA

Liufangjing Biotechnology (Yangzhou) Co., Ltd

DUNS: 510194010

Products 1

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

BENZETHONIUM CHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85420-003
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
BENZETHONIUM CHLORIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 1, 2025
FDA Product Classification

INGREDIENTS (8)

COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
COCAMIDE DEAInactive
Code: 92005F972D
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
BENZETHONIUM CHLORIDEActive
Quantity: 0.1 g in 100 g
Code: PH41D05744
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/1/2025

Use

  • As shave gel: Smooth skin when do shaving and help reduce bacteria
  • As body wash: Body cleaning to help reduce bateria
  • As shampoo: Hair cleaning to help redice baterial

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/1/2025

Active Ingredient

Benzethonium Chloride 0.1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/1/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 6/1/2025

Warnings

For external use only

Keep out of eyes, ears, or mouth. In case of contect flush eyes with water

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/1/2025

Stop use and ask a doctor if irritation and redness develop, or if condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/1/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/1/2025

Directions

  • As shave gel: Wet skin and squeeze gel onto finger tips. Spread gel evenly on skin and shave
  • As body wash: Squeeze body wash onto hands or wash cloth. Apply, lather, and rinse
  • As shampoo: Wet hair, apply shampoo, work up a rich lather and rinse.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/1/2025

Inactive ingredients

Water, Cocamidepropyl Betain, Sodium Lauyl Sufate, Cocamide Dea, Sodium Chloride, DMDM Hydantoin, Frgrance, Citric Acid

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