FDA.reportPublic FDA data

OPTISAFE ANTISEPTIC HAND SANITIZER

Manufacturer
BABU RAM OM PRAKASH
Effective date
2020-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:02

Label at a glance#

ProductOPTISAFE ANTISEPTIC HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin  recommended for repeated use for use when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin 
  • recommended for repeated use
  • for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame.

For external use only 

Do not use 

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

When using this product

• do not get into eyes. In case of contact, rinse eyes thoroughly with water.

• do not inhale or ingest.

Stop use and ask a doctor if 

• irritation and redness develop • condition persists for more than 72 hours

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

Other information

STORAGE AND HANDLING SECTION

• store between 15-30°C (59-86°F)

• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera (Aloe barbadensis) leaf juice, carbomer 934, fragrance, glycerin, propylene glycol, tocopherol acetate (vitamin E), triethanolamine

OTC - QUESTIONS SECTION

Questions? +1-855-494-3767

You may also report serious side effects to this phone number. Mon-Fri 9.00 AM - 5.00 PM

SPL UNCLASSIFIED SECTION

Microgen® 

Redefining Hygiene...

Manufactured by: Babu Ram Om Prakash
(A Unit of Microgen Hygiene Pvt. Ltd.)
Trilokpur Road, Village-Ogli, Kala Amb, Himachal Pradesh, India, 173 030

HO: 614, Midas, Sahar Plaza, Andheri(E), Mumbai, India, 400 059. Website: www.microgenindia.co

COUNTRY OF ORIGIN: INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OptisfenewOptisfenew

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75043-060-012024-01-30C16284748780-11030e365-3d43-111a-e063-dadaa90a10e2OPTISAFE ANTISEPTIC HAND SANITIZER
75043-060-022024-01-30C16284748780-11030e365-3d43-111a-e063-dadaa90a10e2OPTISAFE ANTISEPTIC HAND SANITIZER
75043-060-032024-01-30C16284748780-11030e365-3d43-111a-e063-dadaa90a10e2OPTISAFE ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75043-060-01OPTISAFE ANTISEPTIC HAND SANITIZER118 mL in 1 BOTTLEGEL1181
75043-060-02OPTISAFE ANTISEPTIC HAND SANITIZER237 mL in 1 BOTTLEGEL2371
75043-060-03OPTISAFE ANTISEPTIC HAND SANITIZER473 mL in 1 BOTTLEGEL4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75043-060OPTISAFE ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [BABU RAM OM PRAKASH]1Legacy NDC, 3 package rows20200508_0b19d929-e1a4-4722-9a1a-9c8eafcf867e.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
75043-06075043-060-01, 75043-060-02, 75043-060-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML · Source PDF

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
dbe72a96-80b3-4503-aefb-ebf4304786660b19d929-e1a4-4722-9a1a-9c8eafcf867e2020-05-05WarningsExact identifier
spl id: dbe72a96-80b3-4503-aefb-ebf430478666
spl set id: 0b19d929-e1a4-4722-9a1a-9c8eafcf867e

Reported adverse events (FAERS/openFDA)#

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