FDA.reportPublic FDA data

(Biotemed) Instant Hand Sanitizer

Manufacturer
Qingdao Health Ocean Biopharmaceutical Co., Ltd.
Effective date
2020-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:28

Label at a glance#

Product(Biotemed) Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

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

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

ethyl Alcohol 60%-70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

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

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 77917-001-13 500ml500ml

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136970815480035GTIN-13: 6970815480035
EAN-13: 6970815480035
GTIN storage (14 digits): 06970815480035		500ml label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77917-001-012022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-022022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-032022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-042022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-052022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-062022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-072022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-082022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-092022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-102022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-112022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-122022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer
77917-001-132022-01-28C16284748780-1d6a99b39-f3e5-a426-e053-dadaa90af4c2Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77917-001-01(Biotemed) Instant Hand Sanitizer5 mL in 1 BOTTLEGEL51
77917-001-02(Biotemed) Instant Hand Sanitizer10 mL in 1 BOTTLEGEL101
77917-001-03(Biotemed) Instant Hand Sanitizer20 mL in 1 BOTTLEGEL201
77917-001-04(Biotemed) Instant Hand Sanitizer30 mL in 1 BOTTLEGEL301
77917-001-05(Biotemed) Instant Hand Sanitizer40 mL in 1 BOTTLEGEL401
77917-001-06(Biotemed) Instant Hand Sanitizer50 mL in 1 BOTTLEGEL501
77917-001-07(Biotemed) Instant Hand Sanitizer60 mL in 1 BOTTLEGEL601
77917-001-08(Biotemed) Instant Hand Sanitizer80 mL in 1 BOTTLEGEL801
77917-001-09(Biotemed) Instant Hand Sanitizer100 mL in 1 BOTTLEGEL1001
77917-001-10(Biotemed) Instant Hand Sanitizer120 mL in 1 BOTTLEGEL1201
77917-001-11(Biotemed) Instant Hand Sanitizer250 mL in 1 BOTTLEGEL2501
77917-001-12(Biotemed) Instant Hand Sanitizer300 mL in 1 BOTTLEGEL3001
77917-001-13(Biotemed) Instant Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77917-001(BIOTEMED) INSTANT HAND SANITIZER (ALCOHOL) GEL [QINGDAO HEALTH OCEAN BIOPHARMACEUTICAL CO., LTD.]1Legacy NDC, 13 package rows20200524_a661a6c8-0eb3-0b28-e053-2a95a90a66fe.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77917-00177917-001-01, 77917-001-02, 77917-001-03, 77917-001-05, 77917-001-04, 77917-001-06, 77917-001-07, 77917-001-08, 77917-001-09, 77917-001-10, 77917-001-11, 77917-001-12, 77917-001-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
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
a661a0a2-dd18-a7a4-e053-2995a90aa041a661a6c8-0eb3-0b28-e053-2a95a90a66fe2020-05-24WarningsExact identifier
spl id: a661a0a2-dd18-a7a4-e053-2995a90aa041
spl set id: a661a6c8-0eb3-0b28-e053-2a95a90a66fe

Reported adverse events (FAERS/openFDA)#

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