Bactive Hand Sanitizer

Manufacturer
Zuru LLC | Opal Cosmetics (Huizhou) Limited
Effective date
2020-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:25:20

Label at a glance#

ProductBactive Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

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

Store between 15-30C (59-86F) use within 12 months of opening may discolour some fabrics harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeat use

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor

  • If irritation and redness develop.
  • If condition persists for more than 72 hours consult a doctor.

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

  • 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

  • Store between 15-30C (59-86F)
  • use within 12 months of opening
  • may discolour some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbedensis leaf extract, aminomethyl propanol, fragrance, glycerin, maltodextrin, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL 50 mL label50 mL label

500 mL 500 mL label500 mL label

2L 2L label2L label

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76658-115BACTIVE HAND SANITIZER (ETHYL ALCOHOL) GEL [ZURU LLC]1Legacy NDC20200618_a56bec5a-d34c-2568-e053-2995a90a5ffb.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
76658-11576658-115-01, 76658-115-09, 76658-115-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
a474cb7b-8818-f109-e053-2995a90abcd5a56bec5a-d34c-2568-e053-2995a90a5ffb2020-06-16WarningsExact identifier
spl id: a474cb7b-8818-f109-e053-2995a90abcd5
spl set id: a56bec5a-d34c-2568-e053-2995a90a5ffb

Reported adverse events (FAERS/openFDA)#

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