MedPath

bolor sanitizing hand wipes

Approved
Approval ID

357e2190-5c43-86ba-e063-6294a90a97e6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 29, 2025

Manufacturers
FDA

EcoRhine LLC

DUNS: 131855436

Products 1

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

bolor sanitizing hand wipes

PRODUCT DETAILS

NDC Product Code85577-002
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJune 29, 2025
Generic Namebolor sanitizing hand wipes

INGREDIENTS (6)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCEROL FORMALInactive
Code: 3L7GR2604E
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
LONICERA CAPRIFOLIUM FLOWERING TOPInactive
Code: 1X0T378SXY
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.12 mg in 100 mg
Code: F5UM2KM3W7
Classification: ACTIB
CENTELLA ASIATICAInactive
Code: 7M867G6T1U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/28/2025

Drug Facts Active ingredient Purpose Benzalkonium chloride 0.12% Antimicrobial Uses Hand sanitizer to help reduce bacteria on skin Recommended for repeated use When using this product avoid contact with eyes. In case of contact, flush eyes with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years age should be supervised when using this product. Stop use and ask a doctor if irritation and/or rash occurs and persists for more than 72 hours. Warnings For external use only Directions Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe. Rub hands together briskly to dry your hands. Dispose of wipe. Do not flush. Inactive ingredients Aloe Barbadensis Leaf Extract, Centella AsiaƟca Extract, Chlorhexidine Diacetate, Deionized Water, Ethylhexylglycerin, Glycerol, Lonicera Caprifolium Extract.

60 Bags30 Bags10 Bags6 Pcs

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/1/2025

When using this product avoid contact with eyes. In case of contact, flush eyes with water

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/1/2025

Active ingredient Purpose

Benzalkonium chloride 0.12% Antimicrobial

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/1/2025

Purpose

Antimicrobial

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/1/2025

Directions Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe. Rub hands together briskly to dry your hands. Dispose of wipe. Do not flush.

WARNINGS SECTION

LOINC: 34071-1Updated: 4/1/2025

Warnings For external use only

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/1/2025

Inactive ingredients Aloe Barbadensis Leaf Extract, Centella Asiatica Extract, Chlorhexidine Diacetate, Deionized Water, Ethylhexylglycerin, Glycerol, Lonicera Caprifolium Extract.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/1/2025

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years age should be supervised when using this product.

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bolor sanitizing hand wipes - FDA Drug Approval Details