FDA.reportPublic FDA data

EQUINOX

Manufacturer
ATA FOOD LTD LIABILITY CO
Effective date
2020-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:54

Label at a glance#

ProductEQUINOX
Active ingredientALCOHOL
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 o C (59-86 o F). Avoid freezing and excessive heat above 40 o C (104 o F).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

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

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 or rash occurs. These may be signs of a serious condition.

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

  • 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 15-30oC (59-86oF).
  • Avoid freezing and excessive heat above 40oC (104oF).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized water, glycerin, aloe vera

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79229-002-012022-01-28C16284748780-1d6a99b39-dd6a-a426-e053-dadaa90af4c21a40dd2d-3cef-4fd2-bb96-a23fc3f5106f
79229-002-022022-01-28C16284748780-1d6a99b39-dd6a-a426-e053-dadaa90af4c21a40dd2d-3cef-4fd2-bb96-a23fc3f5106f
79229-002-032022-01-28C16284748780-1d6a99b39-dd6a-a426-e053-dadaa90af4c21a40dd2d-3cef-4fd2-bb96-a23fc3f5106f
79229-002-042022-01-28C16284748780-1d6a99b39-dd6a-a426-e053-dadaa90af4c21a40dd2d-3cef-4fd2-bb96-a23fc3f5106f
79229-002-052022-01-28C16284748780-1d6a99b39-dd6a-a426-e053-dadaa90af4c21a40dd2d-3cef-4fd2-bb96-a23fc3f5106f
79229-002-062022-01-28C16284748780-1d6a99b39-dd6a-a426-e053-dadaa90af4c21a40dd2d-3cef-4fd2-bb96-a23fc3f5106f
79229-002-072022-01-28C16284748780-1d6a99b39-dd6a-a426-e053-dadaa90af4c21a40dd2d-3cef-4fd2-bb96-a23fc3f5106f
79229-002-082022-01-28C16284748780-1d6a99b39-dd6a-a426-e053-dadaa90af4c21a40dd2d-3cef-4fd2-bb96-a23fc3f5106f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79229-002-01EQUINOX100 mL in 1 DRUMGEL1001
79229-002-02EQUINOX200 mL in 1 DRUMGEL2001
79229-002-03EQUINOX500 mL in 1 BOTTLE, PLASTICGEL5001
79229-002-04EQUINOX1000 mL in 1 DRUMGEL10001
79229-002-05EQUINOX5000 mL in 1 DRUMGEL50001
79229-002-06EQUINOX10000 mL in 1 DRUMGEL100001
79229-002-07EQUINOX20000 mL in 1 DRUMGEL200001
79229-002-08EQUINOX30000 mL in 1 DRUMGEL300001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79229-002EQUINOX (ALCOHOL) GEL [ATA FOOD LTD LIABILITY CO]1Legacy NDC, 8 package rows20200711_1a40dd2d-3cef-4fd2-bb96-a23fc3f5106f.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
79229-00279229-002-01, 79229-002-02, 79229-002-03, 79229-002-04, 79229-002-05, 79229-002-06, 79229-002-07, 79229-002-08

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
69db479e-b594-47aa-8133-0999dcdced7b1a40dd2d-3cef-4fd2-bb96-a23fc3f5106f2020-07-09WarningsExact identifier
spl id: 69db479e-b594-47aa-8133-0999dcdced7b
spl set id: 1a40dd2d-3cef-4fd2-bb96-a23fc3f5106f

Reported adverse events (FAERS/openFDA)#

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