FDA.reportPublic FDA data

50563-314/315/316/ G0XAHS05_G0XAHS06

Manufacturer
ENCHANTE ACCESSORIES INC. | Xiamen Afgamarine Biotechnology Co., Ltd.
Effective date
2020-10-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:23

Label at a glance#

ProductBODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER 2 Pack PEPPERMINT and WINTER BERRY
Active ingredientALCOHOL
Label structure19 sections

Indications and uses

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

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing

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 PEPPERMINT

SPL UNCLASSIFIED SECTION

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER PEPPERMINT

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. Flammable.

Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product, keep out of eyes, ears, and mouth. 
In case of contact with eyes, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or rash occurs. These may be signs of a serious condition

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing

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

Carbomer, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Water

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER WINTER BERRY

SPL UNCLASSIFIED SECTION

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER WINTER BERRY

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. Flammable.

Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product, keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or rash occurs. These may be a sign of serious condition

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing

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

Carbomer, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
50563-316-012022-01-28C16284748780-1d6a99b39-e4a7-a426-e053-dadaa90af4c250563-314/315/316/ G0XAHS05_G0XAHS06

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50563-314-01BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER 2 Pack PEPPERMINT and WINTER BERRY30 mL in 1 BOTTLESOLUTION30 mL75 mL in 100mL1
50563-315-01BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER 2 Pack PEPPERMINT and WINTER BERRY30 mL in 1 BOTTLESOLUTION30 mL75 mL in 100mL1
50563-316-01BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER 2 Pack PEPPERMINT and WINTER BERRY1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50563-314BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER 2 PACK PEPPERMINT AND WINTER BERRY (ALCOHOL) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20201010_f08cec1f-0853-4a82-9b9a-de4188e14c22.zip
50563-315BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER 2 PACK PEPPERMINT AND WINTER BERRY (ALCOHOL) KIT [ENCHANTE ACCESSORIES INC.]1Unmatched20201010_f08cec1f-0853-4a82-9b9a-de4188e14c22.zip
50563-316BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER 2 PACK PEPPERMINT AND WINTER BERRY (ALCOHOL) KIT [ENCHANTE ACCESSORIES INC.]1Legacy NDC, 3 package rows20201010_f08cec1f-0853-4a82-9b9a-de4188e14c22.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
50563-31650563-316-01
50563-31450563-314-01
50563-31550563-315-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
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
b1426006-7fc7-e197-e053-2a95a90a6889f08cec1f-0853-4a82-9b9a-de4188e14c222020-10-09WarningsExact identifier
spl id: b1426006-7fc7-e197-e053-2a95a90a6889
spl set id: f08cec1f-0853-4a82-9b9a-de4188e14c22

Reported adverse events (FAERS/openFDA)#

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