Sanidry

Manufacturer
QUIMICA ROSMAR S.A. DE C.V.
Effective date
2021-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:09

Label at a glance#

ProductSanidry
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Remove wipes Rub hands together briskly until dry. No rinsing required. Do not reuse the towel, dispose of it immediately after use.

Storage and handling

Store at temperature below 110F(43C) Do not puncture or incinerate container

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

For hand sanitizing to decrease bacteria on the skin when water and soap are not available.

Recommended for repeated use.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • Do not use near eyes.

OTC - WHEN USING SECTION

When using this product, do not use near eyes. If contact occurs, flush thoroughly with water.

OTC - STOP USE SECTION

Stop use and contact a doctor if irritation or redness persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Remove wipes
  • Rub hands together briskly until dry. No rinsing required.
  • Do not reuse the towel, dispose of it immediately after use.

Other information

STORAGE AND HANDLING SECTION

  • Store at temperature below 110F(43C)
  • Do not puncture or incinerate container

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water USP, glycerin

RECENT MAJOR CHANGES SECTION

Indications and Usage

Dosage and Administration

Active ingredients

Inactive ingredients

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

300 units NDC: 77251-006-01 Package Label. Principal Display Panel.Package Label. Principal Display Panel.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN2
1489307ethanol 0.7 ML/ML Medicated PadSCD2
1489307ethanol 70 % Medicated PadSY2
1489307ethanol 70 % Medicated WipesSY2
1489307ethyl alcohol 70 % ClothSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77251-006-012024-01-30C16284748780-11030e365-3813-111a-e063-dadaa90a10e277251-006 Sanidry Alcohol 70%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77251-006-01Sanidry1275 mL in 1 BAGCLOTH12752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77251-006SANIDRY (ALCOHOL) CLOTH [QUIMICA ROSMAR S.A. DE C.V.]2Legacy NDC, 1 package rows20210121_b8285f8f-e16c-75a7-e053-2a95a90a1742.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77251-00677251-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b9354da3-0965-6509-e053-2995a90a7e19b8285f8f-e16c-75a7-e053-2a95a90a17422021-01-18WarningsExact identifier
spl id: b9354da3-0965-6509-e053-2995a90a7e19
spl set id: b8285f8f-e16c-75a7-e053-2a95a90a1742

Reported adverse events (FAERS/openFDA)#

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