FDA.reportPublic FDA data

snugell ​® ​ ​ ​ CPAP MASK SPRAY

Manufacturer
QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:59

Label at a glance#

ProductSnugell
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

• Spray onto your CPAP cushion or CPAP machine and then gently wipe with a paper towel or a soft towel to clean. • Children under 6 years of age should be supervised when using this product.

Storage and handling

• Avoid freezing and store below 110F (43C). • Dispose of the empty can in a recycling bin.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% (w/w)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do Not Use
• On children less than 2 months of age 
• Near eyes or on open skin wounds

When using this product ​avoid contacting with eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor ​if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children. ​If swallowed, get medical help or contact a poison control center right away at 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

• Spray onto your CPAP cushion or CPAP machine and then gently wipe with a paper towel or a soft towel to clean.
• Children under 6 years of age should be supervised when using this product.

Other Information

STORAGE AND HANDLING SECTION

• Avoid freezing and store below 110F (43C).
• Dispose of the empty can in a recycling bin.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, butylene glycol, chamomilla recutita (matricaria) extract, grape seed extract, purified water.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-844-451-6555

SPL UNCLASSIFIED SECTION

Easily Clean and Refresh Your CPAP Mask and Equipment

Alcohol Free
WITH
Aloe Vera

Distributed by:
Snugell, LLC
Miami, FL 33015
www.snugell.com

MADE IN CHINA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

snugell CPAP MASK SPRAYsnugell CPAP MASK SPRAY

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN2
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD2
1039012benzalkonium chloride 0.13 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80671-005-332025-01-07C16284748780-10191ceaa-649a-198a-e063-dbdaa90aec3esnugell ​® ​ ​ ​ CPAP MASK SPRAY
80671-005-332023-07-28C16284748780-10191ceaa-649a-198a-e063-dbdaa90aec3esnugell ​® ​ ​ ​ CPAP MASK SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80671-005-33Snugell473 mL in 1 BOTTLESPRAY4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80671-005SNUGELL (BENZALKONIUM CHLORIDE) SPRAY [QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD]2Legacy NDC, 1 package rows20250108_b4f6852c-5044-4ab9-8395-4ce8bf1d0a70.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80671-00580671-005-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
WATER059QF0KO0RIACT

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
13d39e35-564f-4aa5-94e0-cdced58aa01ab4f6852c-5044-4ab9-8395-4ce8bf1d0a702024-12-17WarningsExact identifier
spl id: 13d39e35-564f-4aa5-94e0-cdced58aa01a
spl set id: b4f6852c-5044-4ab9-8395-4ce8bf1d0a70

Reported adverse events (FAERS/openFDA)#

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