Neutrogel

Manufacturer
QUIMICA ROSMAR S.A DE C.V
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:57

Label at a glance#

ProductNeutrogel
Active ingredientBENZETHONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Wet as needed Place enough product in your hand Rub gently for at leats 30 seconds Wash skin, rinse thoroughly and dry

Storage and handling

Store at temperature below 110F (43C)

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

Benzethonium chloride 0.10% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • For washing sanitizing hands
  • Helps reduce bacteria on the skin that potentially can cause disease

Warnings

WARNINGS SECTION

For external use only.

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 do not use

  • On children less than 2 months of age
  • On open skin wounds

OTC - STOP USE SECTION

Stop use and ask 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet as needed
  • Place enough product in your hand
  • Rub gently for at leats 30 seconds
  • Wash skin, rinse thoroughly and dry

Other information

STORAGE AND HANDLING SECTION

  • Store at temperature below 110F (43C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium lauryl ether sulfate, cocamidopropyl betaine, cocamide DEA, glycerin, propylene glycol, sodium chloride, citric acid, DMDM hydantoin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(4000 mL)(4000 mL)4000 mL NDC: 77251-008-01

200000 mL NDC: 77251-008-02

20000 mL NDC : 77251-008-03 20000 mL20000 mL

1000 mL NDC: 77251-008-04 1000 mL1000 mL

500 mL NDC: 77251-008-05 500 mL500 mL

250 mL NDC: 77251-008-06 250 mL250 mL 200000 mL200000 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053207benzethonium chloride 0.1 % Medicated Liquid SoapPSN1
1053207benzethonium chloride 1 MG/ML Medicated Liquid SoapSCD1
1053207benzethonium chloride 0.1 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77251-008-01Neutrogel4000 mL in 1 CONTAINERGEL40001
77251-008-02Neutrogel200000 mL in 1 CONTAINERGEL2000001
77251-008-03Neutrogel20000 mL in 1 CONTAINERGEL200001
77251-008-04Neutrogel1000 mL in 1 POUCHGEL10001
77251-008-05Neutrogel500 mL in 1 POUCHGEL5001
77251-008-06Neutrogel250 mL in 1 POUCHGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77251-008NEUTROGEL (SOAP) GEL [QUIMICA ROSMAR S.A DE C.V]1Legacy NDC, 6 package rows20210115_b8421201-ea06-388d-e053-2995a90a2ecb.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77251-00877251-008-01, 77251-008-02, 77251-008-03, 77251-008-04, 77251-008-05, 77251-008-06

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

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
b8420854-8e2a-42df-e053-2995a90a209eb8421201-ea06-388d-e053-2995a90a2ecb2021-01-12WarningsExact identifier
spl id: b8420854-8e2a-42df-e053-2995a90a209e
spl set id: b8421201-ea06-388d-e053-2995a90a2ecb

Reported adverse events (FAERS/openFDA)#

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