Hand Sanitizer

Manufacturer
FIFTEEN DEGREES co.,ltd | FARMER'S GRAIN KOREA LTD
Effective date
2021-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:36:43

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Spray a small amount of product into palm of hand. Rub thoroughly over all surfaces of both hands. Supervise children under 6 years of age when using this product.

Storage and handling

Store between 10-30C (59-86F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Topical Antimicrobial

Purpose

OTC - PURPOSE SECTION

Topical Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

OTC - WHEN USING SECTION

When using this product, do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • Spray a small amount of product into palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Supervise children under 6 years of age when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store between 10-30C (59-86F)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, citrus limon (lemon) peel oil, limonene, citral

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 mL NDC: 74753-784-12

250 mL NDC: 74753-784-25

250ml250ml

120ml120ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN3
1241663ethanol 0.8 ML/ML Topical SpraySCD3
1241663ethanol 80 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74753-784-122021-07-23C16284748780-1c7ccaba7-158d-fd44-e053-dadaa90aa01bHand Sanitizer Fifteen Degrees 80% alcohol
74753-784-252021-07-23C16284748780-1c7ccaba7-158d-fd44-e053-dadaa90aa01bHand Sanitizer Fifteen Degrees 80% alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74753-784-12Hand Sanitizer120 mL in 1 BOTTLE, SPRAYSPRAY1203
74753-784-25Hand Sanitizer250 mL in 1 BOTTLE, SPRAYSPRAY2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74753-784HAND SANITIZER (ALCOHOL) SPRAY [FIFTEEN DEGREES CO.,LTD]3Legacy NDC, 2 package rows20210111_a76cec46-e512-57af-e053-2995a90a9075.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74753-78474753-784-12, 74753-784-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
b87939c5-7d5e-4615-e053-2a95a90af8b5a76cec46-e512-57af-e053-2995a90a90752021-01-09WarningsExact identifier
spl id: b87939c5-7d5e-4615-e053-2a95a90af8b5
spl set id: a76cec46-e512-57af-e053-2995a90a9075

Reported adverse events (FAERS/openFDA)#

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