FDA.reportPublic FDA data

BIOFRESH HAND SANITIZER

Manufacturer
HINDUSTAN HERBAL COSMETICS
Effective date
2020-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:10

Label at a glance#

ProductBIOFRESH HAND SANITIZER
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredient :

OTC - ACTIVE INGREDIENT SECTION

Alcohol IP (Denatured) eq. to absolute alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

​Uses: • For handwashing to decrease bacteria on the skin • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

Flammable, Keep away from heat or flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help

DOSAGE & ADMINISTRATION SECTION

​Directions • wet hands thoroughly with product • briskly rub hands together until dry • supervise children under 6 years in the use of this product

INACTIVE INGREDIENT SECTION

Ingredients: Alcohol IP (Denatured) 70% v/v, Glycerin, Propylene Glycol, Tea Tree Extract, Aloevera Extract, Triethanolamine, Color, Purified Water

SPL UNCLASSIFIED SECTION

Kills 99.99% of Germs

Protects Hands

Refreshing & Protection Gel

With Moisturizer Neem Extract & Vitamins E & A

Manufactured by :

HINDUSTAN HERBAL COSMETICS

Visit us : www.biofreshherbals.com

Made In India​

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOFRS1BIOFRS1PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77104-999-012021-07-23C16284748780-1c7ccaba7-111f-fd44-e053-dadaa90aa01bBio Fresh TM PURE HERBAL HAND SANITIZER
77104-999-022021-07-23C16284748780-1c7ccaba7-111f-fd44-e053-dadaa90aa01bBio Fresh TM PURE HERBAL HAND SANITIZER
77104-999-032021-07-23C16284748780-1c7ccaba7-111f-fd44-e053-dadaa90aa01bBio Fresh TM PURE HERBAL HAND SANITIZER
77104-999-042021-07-23C16284748780-1c7ccaba7-111f-fd44-e053-dadaa90aa01bBio Fresh TM PURE HERBAL HAND SANITIZER
77104-999-052021-07-23C16284748780-1c7ccaba7-111f-fd44-e053-dadaa90aa01bBio Fresh TM PURE HERBAL HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77104-999-01BIOFRESH HAND SANITIZER60 mL in 1 BOTTLEGEL602
77104-999-02BIOFRESH HAND SANITIZER100 mL in 1 BOTTLEGEL1002
77104-999-03BIOFRESH HAND SANITIZER250 mL in 1 BOTTLEGEL2502
77104-999-04BIOFRESH HAND SANITIZER500 mL in 1 BOTTLEGEL5002
77104-999-05BIOFRESH HAND SANITIZER30 mL in 1 BOTTLEGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77104-999BIOFRESH HAND SANITIZER (ALCOHOL) GEL [HINDUSTAN HERBAL COSMETICS]2Legacy NDC, 5 package rows20200820_20468d08-261c-4dfa-9c0f-b60541b3fb80.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77104-99977104-999-04, 77104-999-03, 77104-999-02, 77104-999-01, 77104-999-05

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
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
1026ec96-7d08-4378-98fb-b52104f8986620468d08-261c-4dfa-9c0f-b60541b3fb802020-08-19WarningsExact identifier
spl id: 1026ec96-7d08-4378-98fb-b52104f89866
spl set id: 20468d08-261c-4dfa-9c0f-b60541b3fb80

Reported adverse events (FAERS/openFDA)#

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