FDA.reportPublic FDA data

SweatWellth SAFE SMART Hand Sanitizer

Manufacturer
BOOM LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:44:55

Label at a glance#

ProductSweatWellth SAFE SMART Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

to decrease bacteria on the skin that could cause disease recommend for repeated use

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease
  • recommend for repeated use

Warnings

WARNINGS SECTION

For external use only: hands

Flammable, keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest

Stop and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants

Other Information

SPL UNCLASSIFIED SECTION

  • do not store above 105ºF
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Glycerin, PEG-7 Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Extract, Tocopheryl Acetate

Pacckage Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80236-001-062024-12-20C16284748780-1d6a99b39-7a6b-a426-e053-dadaa90af4c2SweatWellth SAFE SMART Hand Sanitizer
80236-001-062022-01-28C16284748780-1d6a99b39-7a6b-a426-e053-dadaa90af4c2SweatWellth SAFE SMART Hand Sanitizer

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
80236-00180236-001-06

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
ALOE VERA WHOLEKIZ4X2EHYXIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PEG-7 OLEATE7W4ZYQ7UVQIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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
30dc037c-e8f5-4d23-e063-6294a90aeaf1addfe31b-bc98-4d76-e053-2995a90a47bb2025-03-21WarningsExact identifier
spl set id: addfe31b-bc98-4d76-e053-2995a90a47bb

Reported adverse events (FAERS/openFDA)#

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