FDA.reportPublic FDA data

Simply Saline

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-06-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:06

Label at a glance#

ProductSimply Saline Wound Care
Active ingredientBENZETHONIUM CHLORIDE
Label structure11 sections

Indications and uses

First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.

Dosage and administration

before use, expel a short stream of Wound Care to clear nozzle clean the affected area spray a small amount of this product on the area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Wound Care 3 in 1 Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.

Warnings For external use only.

WARNINGS SECTION

Do not use

  • in the eyes or apply over large areas of the body
  • longer that 1 week, unless directed by a doctor

Ask a doctor before use if you have

  • deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

When using this product

  • do not puncture or incinerate
  • store between 59 and 86F (15 and 30C)
  • contents under pressure

OTC - STOP USE SECTION

Stop use and consult a doctor if

  • condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

Directions

DOSAGE & ADMINISTRATION SECTION

  • before use, expel a short stream of Wound Care to clear nozzle
  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times a day
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

OTHER SAFETY INFORMATION

for single patient use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract (aloe vera), benzalkonium chloride, maltodextrin, purified water, sodium bicarbonate, sodium chloride

Product Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sting Free

Arm and Hammer

The standard of Purity

Simply Saline

First Aid Antiseptic

Wound Care

3 in 1

Irrigates

Helps prevent infections

Soothes

Plus Soothing Aloe

7.4 OZ (211 mL)

Image

SACN-08557-05E.jpgSACN-08557-05E.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-700-71Simply SalineWound Care211 mL in 1 CANSPRAY2113
10237-700-72Simply SalineWound Care211 mL in 1 CANSPRAY2113
10237-700-72Simply SalineWound Care2 in 1 PACKAGESPRAY23

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-70010237-700-71, 10237-700-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
MALTODEXTRIN7CVR7L4A2DIACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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
Simply Saline Wound CareBENZETHONIUM CHLORIDE 0.13%Church & Dwight Co., Inc.6c802e91-b69e-cdd0-e053-2991aa0aa7812025-06-01WarningsExact identifier
ndc (package): 10237-700-72
ndc (package): 10237-700-71
ndc (product): 10237-700
ndc11 (package): 10237070072
ndc11 (package): 10237070071
spl id: 3855eab5-57ab-b144-e063-6294a90a8bc5
spl set id: 6c802e91-b69e-cdd0-e053-2991aa0aa781

Reported adverse events (FAERS/openFDA)#

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