FDA.reportPublic FDA data

A Breath of Fresh Air

Manufacturer
SANSUNG LIFE & SCIENCE CO., LTD.
Effective date
2015-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:37

Label at a glance#

ProductA Breath of Fresh Air
Active ingredientWitch Hazel
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Hamamelis Virginiana (Witch Hazel) Water 0.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Butylene Glycol, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Portulaca Oleracea Extract, Betaine, Acer Saccharum (Sugar Maple) Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Ethylhexylglycerin, Caprylyl Glycol, Arnica Montana Flower Extract, Xanthan Gum, Morus Alba Bark Extract, Houttuynia Cordata Extract, Sodium Hyaluronate, Fragrance, Ledum Palustre Extract, Achillea Millefolium Extract, Saururus Chinensis Extract, Artemisia Absinthium Extract, Artemisia Capillaris Flower Extract, Ecklonia Cava Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Gentiana Lutea Root Extract

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician. Use immediately after opening. Store in cool and dry place. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indication and usage: Step 1. Remove mask from the pouch and gently unfold. Step 2. Apply mask to cleansed skin and smooth to fit contours of face. Step 3. Leave on for 10~15 minutes. Step 4. Discard mask and lightly pat face to help absorb serum into skin.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and administration: 2-3 times a week. Each mask is for one time use only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello packImage of cello pack

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codem.site.naver.com/097fsa breath of fresh air cello pack.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69424-280-012020-01-31C16284748780-19d75b9d0-c991-f424-e053-dadaa90a57cee2540f89-fae8-49bd-bf12-4eb8621a8e4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69424-280-01A Breath of Fresh Air25 mL in 1 CELLO PACKPATCH251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69424-280A BREATH OF FRESH AIR (WITCH HAZEL) PATCH [SANSUNG LIFE & SCIENCE CO., LTD.]1Legacy NDC, 1 package rows20150529_e2540f89-fae8-49bd-bf12-4eb8621a8e4a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Witch HazelACTIVE INGREDIENT101I4J0U341
WITCH HAZELACTIVE MOIETY101I4J0U341
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69424-28069424-280-01

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
Witch Hazel101I4J0U34ACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
93f7e784-5efc-4ada-bd87-0695c889ae48e2540f89-fae8-49bd-bf12-4eb8621a8e4a2015-05-29WarningsExact identifier
spl id: 93f7e784-5efc-4ada-bd87-0695c889ae48
spl set id: e2540f89-fae8-49bd-bf12-4eb8621a8e4a

Reported adverse events (FAERS/openFDA)#

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