FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Manufacturer
Suavecito,Inc. | BMC 1092, Inc. dba Solo Laboratories, Inc. | Suavecito
Effective date
2020-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:14

Label at a glance#

ProductAntibacterial Hand Sanitizer
Active ingredientalcohol
Label structure10 sections

Indications and uses

for hand washing to decrease bacteria on the skin recommended for repeated use

Dosage and administration

wet hands thoroughly with product briskly rub hands together until dry Supervise children in the use of this product.

Storage and handling

store at 20-25° C (68 to 77°F) may discolor certain fabrics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not use in the eyes. In case of contact, rinse eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop and persist 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 poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • Supervise children in the use of this product.

Other Information

STORAGE AND HANDLING SECTION

  • store at 20-25° C (68 to 77°F)
  • may discolor certain fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Peg-60, Almond Glycerides, Aloe Barbadensis Leaf Juice, Triisopropanolamine, Fragrance

SPL UNCLASSIFIED SECTION

Dist. by:
Suavecito, Inc.
Santa Ana, Calif. 92703

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUAVECITO®

ANTIBACTERIAL
HAND SANITIZER

KILLS 99.99% OF ALL GERMS.
WITH ALOE VERA & VITAMIN E.

8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74866-714-082021-07-23C16284748780-1c7ccaba7-0fa2-fd44-e053-dadaa90aa01bAntibacterial Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74866-714-08Antibacterial Hand Sanitizer237 mL in 1 BOTTLEGEL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74866-714ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [SUAVECITO,INC.]1Legacy NDC, 1 package rows20200501_b381ab32-8f15-4d3b-b1fc-23bb62a36c16.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
74866-71474866-714-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
alcohol3K9958V90MACTIB
Propylene Glycol6DC9Q167V3IACT
water059QF0KO0RIACT
PEG-60 ALMOND GLYCERIDES4Y0E651N0FIACT
aloe vera leafZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
triisopropanolamineW9EN9DLM98IACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT

Source Document#

Source XML · Source PDF

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
3e5cb601-fe14-4ffa-a23b-dfa09da42bdbb381ab32-8f15-4d3b-b1fc-23bb62a36c162020-04-15WarningsExact identifier
spl id: 3e5cb601-fe14-4ffa-a23b-dfa09da42bdb
spl set id: b381ab32-8f15-4d3b-b1fc-23bb62a36c16

Reported adverse events (FAERS/openFDA)#

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