FDA.reportPublic FDA data

SP NEWGEL

Manufacturer
SOUTHERN PHARMA COMPANY LIMITED
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:30

Label at a glance#

ProductSP NEWGEL
Active ingredientALCOHOL
Label structure12 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 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

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 80% v/v. Purpose: Antiseptic

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING 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 or rash occurs. These may be signs of a serious condition.
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 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 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe, benzalkonium chloride, carbomer, fragnance, glycerin, hypromellose, polysorbat 80, purified water USP.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 78125-001-02

100 mL label100 mL label

250 mL NDC: 78125-001-03

250 mL label250 mL label

500 mL NDC: 78125-001-04

500 mL label500 mL label

980 mL NDC: 78125-001-05

980 mL label980 mL label

3780 mL NDC: 78125-001-06

3780 mL label3780 mL label

5000 mL 78125-001-07

5000 mL label5000 mL label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78125-001-012022-01-28C16284748780-1d6a99b39-a808-a426-e053-dadaa90af4c2a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-022022-01-28C16284748780-1d6a99b39-a808-a426-e053-dadaa90af4c2a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-032022-01-28C16284748780-1d6a99b39-a808-a426-e053-dadaa90af4c2a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-042022-01-28C16284748780-1d6a99b39-a808-a426-e053-dadaa90af4c2a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-052022-01-28C16284748780-1d6a99b39-a808-a426-e053-dadaa90af4c2a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-062022-01-28C16284748780-1d6a99b39-a808-a426-e053-dadaa90af4c2a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-072022-01-28C16284748780-1d6a99b39-a808-a426-e053-dadaa90af4c2a5fcb894-25d5-4150-e053-2995a90adb0b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78125-001-01SP NEWGEL50 mL in 1 BOTTLE, PLASTICGEL502
78125-001-02SP NEWGEL100 mL in 1 BOTTLEGEL1002
78125-001-03SP NEWGEL250 mL in 1 BOTTLE, PUMPGEL2502
78125-001-04SP NEWGEL500 mL in 1 BOTTLE, PUMPGEL5002
78125-001-05SP NEWGEL980 mL in 1 BOTTLE, PUMPGEL9802
78125-001-06SP NEWGEL3780 mL in 1 CANGEL37802
78125-001-07SP NEWGEL5000 mL in 1 CANGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78125-001SP NEWGEL (ALCOHOL) GEL [SOUTHERN PHARMA COMPANY LIMITED]2Legacy NDC, 7 package rows20200609_a5fcb894-25d5-4150-e053-2995a90adb0b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78125-00178125-001-01, 78125-001-02, 78125-001-03, 78125-001-04, 78125-001-05, 78125-001-06, 78125-001-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HYPROMELLOSES3NXW29V3WOIACT
ALOEV5VD430YW9IACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
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
a79548c3-a019-d774-e053-2a95a90a422da5fcb894-25d5-4150-e053-2995a90adb0b2020-06-08WarningsExact identifier
spl id: a79548c3-a019-d774-e053-2a95a90a422d
spl set id: a5fcb894-25d5-4150-e053-2995a90adb0b

Reported adverse events (FAERS/openFDA)#

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