FDA.reportPublic FDA data

SANI SAFE Hand Sanitizer

Manufacturer
ATLANTIC CARE CHEMICALS PRIVATE LIMITED
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:04

Label at a glance#

ProductSANI SAFE Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure9 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 15-30°C (59-86F) • Avoid freezing and excessive heat above 40° ​ C (104F)

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose: Antiseptic

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Component

Isopropyl alcohol - 72 % (v/v)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Boro glycerine, Water, Vitamin E

INDICATIONS & USAGE SECTION

Use: Hand Sanitizer to help reduce microbes that potentially can cause disease. For use when soap and water are not available. It can be used for surgical hand sanitizer.

WARNINGS 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 occurs, please consult a doctor.

Do not use

• In children less than 2 months of age.

• On open skin wounds.

Warning

• For external use only

• Flammable: Keep away from heat or flame

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of Reach of Children

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 15-30°C (59-86F)

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

SPL UNCLASSIFIED SECTION

Manufactured by:
Atlantic Care Chemicals. Pvt. Ltd
Industrial Development Plot,
Alappuzha, Kerala, India.

9001:2015

ISO CERTIFIED COMPANY

PASSION FOR INNOVATION

care@atlanticchemicals.com
www.atlanticchemicals.com

MADE IN INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287034isopropyl alcohol 72 % Topical GelPSN1
2287034isopropyl alcohol 0.72 ML/ML Topical GelSCD1
2287034isopropyl alcohol 72 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77249-102-012022-01-28C16284748780-1d6a99b39-a6f4-a426-e053-dadaa90af4c2SANI SAFE Hand sanitizer
77249-102-022022-01-28C16284748780-1d6a99b39-a6f4-a426-e053-dadaa90af4c2SANI SAFE Hand sanitizer
77249-102-052022-01-28C16284748780-1d6a99b39-a6f4-a426-e053-dadaa90af4c2SANI SAFE Hand sanitizer
77249-102-452022-01-28C16284748780-1d6a99b39-a6f4-a426-e053-dadaa90af4c2SANI SAFE Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77249-102-01SANI SAFE Hand Sanitizer0.1 L in 1 BOTTLELIQUID0.11
77249-102-02SANI SAFE Hand Sanitizer0.2 L in 1 BOTTLELIQUID0.21
77249-102-05SANI SAFE Hand Sanitizer0.5 L in 1 BOTTLELIQUID0.51
77249-102-45SANI SAFE Hand Sanitizer5 L in 1 CANLIQUID51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77249-102SANI SAFE HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [ATLANTIC CARE CHEMICALS PRIVATE LIMITED]1Legacy NDC, 4 package rows20200529_36ad9650-dcb6-4fc8-ac01-01cf491836ad.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
77249-10277249-102-45, 77249-102-01, 77249-102-02, 77249-102-05

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
ISOPROPYL ALCOHOLND2M416302ACTIB
BOROGLYCERINU3LMU4AN21IACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
d70eec6d-285e-42b1-a306-e75e6022a7c136ad9650-dcb6-4fc8-ac01-01cf491836ad2020-05-20WarningsExact identifier
spl id: d70eec6d-285e-42b1-a306-e75e6022a7c1
spl set id: 36ad9650-dcb6-4fc8-ac01-01cf491836ad

Reported adverse events (FAERS/openFDA)#

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