FDA.reportPublic FDA data

ROUYUN Lavender essential oil portable body care wipes

Manufacturer
Shenzhen Shierjie Biological Engineering Co., LTD
Effective date
2023-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:04:47

Label at a glance#

ProductROUYUN Lavender essential oil portable body care wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Tear open the packaging gap, take out the wet wipes, lay them flat and open them to wipe the skin without washing with water. Daily skin and sweat wiping, suitable for any skin color and type, suitable for both men and women of all ages. Unable to prevent the spread of sexually transmitted diseases.

Storage and handling

Store in a cool and dry place.At room temperature, away from heat sources, and away from direct sunlight.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.09%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Uses Wipes help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Keep away from heat.For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not wipe wounds or swollen wounds.

When Using

OTC - WHEN USING SECTION

pay attention to discarding the garbage bin.

Stop Use

OTC - STOP USE SECTION

If there is any discomfort during use, please stop using immediately.

Ask Doctor

OTC - ASK DOCTOR SECTION

If there is any discomfort during use, please stop using immediately.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of infants.

Directions

DOSAGE & ADMINISTRATION SECTION

Tear open the packaging gap, take out the wet wipes, lay them flat and open them to wipe the skin without washing with water.
Daily skin and sweat wiping, suitable for any skin color and type, suitable for both men and women of all ages.
Unable to prevent the spread of sexually transmitted diseases.

Other information

STORAGE AND HANDLING SECTION

Store in a cool and dry place.At room temperature, away from heat sources, and away from direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

001001002002003003004004005005006006007007008008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2671580benzalkonium chloride 0.09 % Medicated PadPSN1
2671580benzalkonium chloride 0.9 MG/ML Medicated PadSCD1
2671580benzalkonium chloride 0.09 % Medicated PadSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43116-033-012025-01-30C16284748780-12cef2736-b61d-d83d-e063-dadaa90ab31f43116-033
43116-033-022025-01-30C16284748780-12cef2736-b61d-d83d-e063-dadaa90ab31f43116-033
43116-033-032025-01-30C16284748780-12cef2736-b61d-d83d-e063-dadaa90ab31f43116-033
43116-033-042025-01-30C16284748780-12cef2736-b61d-d83d-e063-dadaa90ab31f43116-033
43116-033-052025-01-30C16284748780-12cef2736-b61d-d83d-e063-dadaa90ab31f43116-033
43116-033-062025-01-30C16284748780-12cef2736-b61d-d83d-e063-dadaa90ab31f43116-033
43116-033-072025-01-30C16284748780-12cef2736-b61d-d83d-e063-dadaa90ab31f43116-033
43116-033-082025-01-30C16284748780-12cef2736-b61d-d83d-e063-dadaa90ab31f43116-033

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43116-033-01ROUYUN Lavender essential oil portable body care wipes1 in 1 BAGCLOTH11
43116-033-02ROUYUN Lavender essential oil portable body care wipes10 in 1 BOXCLOTH101
43116-033-03ROUYUN Lavender essential oil portable body care wipes16 in 1 BOXCLOTH161
43116-033-04ROUYUN Lavender essential oil portable body care wipes50 in 1 BOXCLOTH501
43116-033-05ROUYUN Lavender essential oil portable body care wipes64 in 1 BOXCLOTH641
43116-033-06ROUYUN Lavender essential oil portable body care wipes80 in 1 BOXCLOTH801
43116-033-07ROUYUN Lavender essential oil portable body care wipes100 in 1 BOXCLOTH1001
43116-033-08ROUYUN Lavender essential oil portable body care wipes128 in 1 BOXCLOTH1281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43116-033ROUYUN LAVENDER ESSENTIAL OIL PORTABLE BODY CARE WIPES CLOTH [SHENZHEN SHIERJIE BIOLOGICAL ENGINEERING CO., LTD]18 package rows20231219_0ccb0278-213a-6b92-e063-6394a90aea16.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43116-03343116-033-01, 43116-033-02, 43116-033-03, 43116-033-04, 43116-033-05, 43116-033-06, 43116-033-07, 43116-033-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ccb0278-213b-6b92-e063-6394a90aea160ccb0278-213a-6b92-e063-6394a90aea162023-12-18WarningsExact identifier
spl id: 0ccb0278-213b-6b92-e063-6394a90aea16
spl set id: 0ccb0278-213a-6b92-e063-6394a90aea16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.