FDA.reportPublic FDA data

Afgamarine, Hand Sanitizer, Ethanol 75%, Gel

Manufacturer
Xiamen Afgamarine Biotechnology Co., Ltd. | A03 Lab of BTS
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:01

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Superise children when they use this product. For occasional and personal dosmetic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Storage and handling

Security Package: Security feature is self-evident. Waste disposal: The disposal of this product and container shall be in accordance with local/national regulations.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial.

Use

INDICATIONS & USAGE SECTION

Recommended uses:

External use to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Cautions and Warning:

DANGER! Flammable warning. Keep away from open flame and sources of heat.
For external use only.

Do not use

OTC - DO NOT USE SECTION

Contraindications:

Do not use on children/infants less than 2 years of age (unless directed by a doctor/physician/health care practitioner/health care provider/health care profession).

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care profession if irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Superise children when they use this product. For occasional and personal dosmetic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other information

STORAGE AND HANDLING SECTION

Security Package: Security feature is self-evident.

Waste disposal: The disposal of this product and container shall be in accordance with local/national regulations.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Carbomer, Parfum, Triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77607-100-012022-01-28C16284748780-1d6a99b39-8c5a-a426-e053-dadaa90af4c2Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-032022-01-28C16284748780-1d6a99b39-8c5a-a426-e053-dadaa90af4c2Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-052022-01-28C16284748780-1d6a99b39-8c5a-a426-e053-dadaa90af4c2Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-082022-01-28C16284748780-1d6a99b39-8c5a-a426-e053-dadaa90af4c2Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-092022-01-28C16284748780-1d6a99b39-8c5a-a426-e053-dadaa90af4c2Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-122022-01-28C16284748780-1d6a99b39-8c5a-a426-e053-dadaa90af4c2Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-152022-01-28C16284748780-1d6a99b39-8c5a-a426-e053-dadaa90af4c2Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-192022-01-28C16284748780-1d6a99b39-8c5a-a426-e053-dadaa90af4c2Afgamarine, Hand Sanitizer, Ethanol 75%, Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77607-100-01Hand Sanitizer30 mL in 1 BOTTLEGEL301
77607-100-03Hand Sanitizer60 mL in 1 BOTTLEGEL601
77607-100-05Hand Sanitizer100 mL in 1 BOTTLEGEL1001
77607-100-08Hand Sanitizer200 mL in 1 BOTTLEGEL2001
77607-100-09Hand Sanitizer236 mL in 1 BOTTLEGEL2361
77607-100-12Hand Sanitizer300 mL in 1 BOTTLEGEL3001
77607-100-15Hand Sanitizer500 mL in 1 BOTTLEGEL5001
77607-100-19Hand Sanitizer946 mL in 1 BOTTLEGEL9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77607-100HAND SANITIZER GEL [XIAMEN AFGAMARINE BIOTECHNOLOGY CO., LTD.]1Legacy NDC, 8 package rows20200521_a61881f7-832e-b943-e053-2995a90a883c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77607-10077607-100-01, 77607-100-03, 77607-100-05, 77607-100-08, 77607-100-09, 77607-100-12, 77607-100-15, 77607-100-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
DICHROSTACHYS CINEREA WHOLEN27D64ME6PIACT
TROLAMINE9O3K93S3TKIACT

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
a61881f7-832f-b943-e053-2995a90a883ca61881f7-832e-b943-e053-2995a90a883c2020-05-20WarningsExact identifier
spl id: a61881f7-832f-b943-e053-2995a90a883c
spl set id: a61881f7-832e-b943-e053-2995a90a883c

Reported adverse events (FAERS/openFDA)#

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