FDA.reportPublic FDA data

careful Hand Sanitizer Spray Orange

Manufacturer
Brainstem Innovations Co.
Effective date
2021-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:24

Label at a glance#

Productcareful Hand Sanitizer Orange
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

• for hand washing to decrease bacteria on the skin. • recommended for repeated use throughout the day

Dosage and administration

• wet hands thoroughly with product • allow to dry without wiping • supervise children under 6 years old • not recommended for infants

Storage and handling

• may discolor certain fabrics • store at room temperature 20° - 25°C (66° - 77° F)

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• for hand washing to decrease bacteria on the skin. • recommended for repeated use throughout the day

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire or flame.

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

Stop use and contact a doctor if irritation or redness develop or lasts for more than 72 hours.

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

Directions

DOSAGE & ADMINISTRATION SECTION

• wet hands thoroughly with product • allow to dry without wiping • supervise children under 6 years old • not recommended for infants

Other information

STORAGE AND HANDLING SECTION

• may discolor certain fabrics • store at room temperature 20° - 25°C (66° - 77° F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Simmondsia Chinensis (Jojoba) seed oil, Parfum, Panthenol, Tocopheryl Acetate (Vitamin E).

SPL UNCLASSIFIED SECTION

With Moisturizing Jojoba Oil, Aloe Vera and Vitamin E

Orange

Kills 99.9% of germs

Sold and distributed by Careful Co.
Seattle, WA 98109

SKU: CRFSPHSO2011-1

Not tested on animals

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN2
1241663ethanol 0.8 ML/ML Topical SpraySCD2
1241663ethanol 80 % Topical SpraySY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80622-555-122022-07-29C16284748780-1e4f33bdf-adb3-d8a0-e053-dadaa90a6e4ecareful Hand Sanitizer Spray Orange

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80622-555-12careful Hand Sanitizer Orange100 mL in 1 BOTTLE, SPRAYSPRAY1002
80622-555-12careful Hand Sanitizer Orange1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80622-555CAREFUL HAND SANITIZER ORANGE (ETHYL ALCOHOL) SPRAY [BRAINSTEM INNOVATIONS CO.]2Legacy NDC, 2 package rows20210128_02a487e6-9afa-4c10-8cf2-7aa505600ccc.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80622-55580622-555-12

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
JOJOBA OIL724GKU717MIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
2feb8b0d-03c2-49c6-baa6-372d94938b4a02a487e6-9afa-4c10-8cf2-7aa505600ccc2021-01-26WarningsExact identifier
spl id: 2feb8b0d-03c2-49c6-baa6-372d94938b4a
spl set id: 02a487e6-9afa-4c10-8cf2-7aa505600ccc

Reported adverse events (FAERS/openFDA)#

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