FDA.reportPublic FDA data

BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS

Manufacturer
ENCHANTE ACCESSORIES INC. | Xiamen Afgamarine Biotechnology Co., Ltd.
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:30

Label at a glance#

ProductBODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS
Active ingredientALCOHOL
Label structure28 sections

Indications and uses

To decrease bacteria on the skin that could cause disease ■Recommended 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

Storage and handling

Do not store above 105F May discolor some fabrics Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Spearmint

SPL UNCLASSIFIED SECTION

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Spearmint

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

■ To decrease bacteria on the skin that could cause disease
■Recommended for repeated use

WARNINGS

WARNINGS SECTION

For external use only, Hands

Flammable. Keep away from heat and flame

When using this product, 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 Use

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation develops

keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

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

STORAGE AND HANDLING SECTION

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Blue 1, Yellow 5

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Unsented

SPL UNCLASSIFIED SECTION

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Unscented

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Alcohol 75%

OTC - PURPOSE SECTION

Purpose:

Antiseptic

INDICATIONS & USAGE SECTION

Uses:

To decrease bacteria on the skin that could cause disease
■Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only, Hands

Flammable. Keep away from heat and flame

When using this product, 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 Use

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

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

STORAGE AND HANDLING SECTION

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Red 33, Blue 1

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Citrus

SPL UNCLASSIFIED SECTION

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Citrus

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease
■Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only, Hands

Flammable. Keep away from heat and flame

When using this product, 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 Use

OTC - DO NOT USE SECTION

Stop use and ask a doctor if skin irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

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

STORAGE AND HANDLING SECTION

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Yellow 5, Red 4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN1
1047755ethanol 0.75 ML/ML Topical SolutionSCD1
1047755ethanol 75 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50563-256-012022-01-28C16284748780-1d6a99b39-471a-a426-e053-dadaa90af4c250563_253/254/255/256_G0ABHS12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-253-01BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS60 mL in 1 BOTTLESOLUTION60 mL75 mL in 100mL1
50563-254-01BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS60 mL in 1 BOTTLESOLUTION60 mL75 mL in 100mL1
50563-255-01BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS60 mL in 1 BOTTLESOLUTION60 mL75 mL in 100mL1
50563-256-01BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-253BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS (ALCOHOL) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20200917_7e65d47d-8229-445e-88fc-8e90d2670aaa.zip
50563-254BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS (ALCOHOL) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20200917_7e65d47d-8229-445e-88fc-8e90d2670aaa.zip
50563-255BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS (ALCOHOL) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20200917_7e65d47d-8229-445e-88fc-8e90d2670aaa.zip
50563-256BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS (ALCOHOL) KIT [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 4 package rows20200917_7e65d47d-8229-445e-88fc-8e90d2670aaa.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50563-25650563-256-01
50563-25350563-253-01
50563-25450563-254-01
50563-25550563-255-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 4X3W0AM1JLXIACT
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
af7b647c-1f3f-68ec-e053-2995a90a219d7e65d47d-8229-445e-88fc-8e90d2670aaa2020-09-16WarningsExact identifier
spl id: af7b647c-1f3f-68ec-e053-2995a90a219d
spl set id: 7e65d47d-8229-445e-88fc-8e90d2670aaa

Reported adverse events (FAERS/openFDA)#

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