Surya Henna Hand Sanitizer

Manufacturer
Surya Nature Inc
Effective date
2020-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:33:44

Label at a glance#

ProductSurya Henna Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions • apply palmful to hands • rub hands together vigorously until dry • supervise children in the use of this product.

Storage and handling

Other Information • Store below 110 º F (43 º C). • May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

USE: Apply a small amount of SURYA HENNA HAND SANITIZER in the
hands palm, massaging lightly, until completely absorbed.
NO RINSE REQUIRED.

Warnings

WARNINGS SECTION

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

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

When using this product do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes.In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops.
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 redness develops.

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

Directions • apply palmful to hands • rub hands together vigorously until dry
• supervise children in the use of this product.

Other information

STORAGE AND HANDLING SECTION

  • Other Information
    • Store below 110 º F (43 º C). • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Alcohol, Aqua, Glycerin (Vegetal), Carbomer, Aminomethyl
Propanol, Aloe Barbadensis Leaf Extract (Aloe Vera), Lawsonia Inermis Leaf Extract
(Henna), Chamomilla Recutita Flower Extract (Camomila), Denatonium Benzoate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

230 ml Label230 ml Label60 ml Label60 ml Label230 mL NDC: 75252-720-10

60mL NDC: 75252-720-20

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75252-720-102022-01-28C16284748780-1d6a99b39-4a78-a426-e053-dadaa90af4c2a2f20587-d107-2649-e053-2995a90a1ea6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75252-720-10Surya Henna Hand Sanitizer230 mL in 1 BOTTLE, PUMPGEL2302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75252-720SURYA HENNA HAND SANITIZER (ETHYL ALCOHOL) GEL [SURYA NATURE INC]2Legacy NDC, 1 package rows20201117_a2f20587-d107-2649-e053-2995a90a1ea6.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75252-72075252-720-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
b3c5d8d9-141b-2146-e053-2995a90a5ddba2f20587-d107-2649-e053-2995a90a1ea62020-11-10WarningsExact identifier
spl id: b3c5d8d9-141b-2146-e053-2995a90a5ddb
spl set id: a2f20587-d107-2649-e053-2995a90a1ea6

Reported adverse events (FAERS/openFDA)#

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