FDA.reportPublic FDA data

NEW NB GEl

Manufacturer
MY PERFUME FACTORY LLC
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:15:08

Label at a glance#

ProductNEW NB NATURALLY BOLD Natural
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using products.

Storage and handling

Store below 110°F(43C°) Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using products.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110°F(43C°)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (water), Glycerin, Propylene Glycol, Carbopol, Aminomethyl Propanol, Tocopheryl Acetate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 ml NDC: 78068-123-5050 ml NDC: 78068-123-50

50 ml NDC: 78068-123-50

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN2
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD2
581698isopropyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78068-123-012022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-052022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-102022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-112022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-122022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-252022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-502022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-602022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-612022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl
78068-123-702022-01-28C16284748780-1d6a99b39-a6e6-a426-e053-dadaa90af4c2NEW NB GEl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78068-123-01NEW NB NATURALLY BOLDNatural1000 mL in 1 BOTTLEGEL10002
78068-123-05NEW NB NATURALLY BOLDNatural500 mL in 1 BOTTLEGEL5002
78068-123-10NEW NB NATURALLY BOLDNatural100 mL in 1 BOTTLEGEL1002
78068-123-11NEW NB NATURALLY BOLDNatural3785 mL in 1 CONTAINERGEL37852
78068-123-12NEW NB NATURALLY BOLDNatural120 mL in 1 BOTTLEGEL1202
78068-123-25NEW NB NATURALLY BOLDNatural250 mL in 1 BOTTLEGEL2502
78068-123-50NEW NB NATURALLY BOLDNatural50 mL in 1 BOTTLEGEL502
78068-123-60NEW NB NATURALLY BOLDNatural60 mL in 1 BOTTLEGEL602
78068-123-61NEW NB NATURALLY BOLDNatural60 mL in 1 BOTTLE, DISPENSINGGEL602
78068-123-70NEW NB NATURALLY BOLDNatural70 mL in 1 BOTTLEGEL702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78068-123NEW NB NATURALLY BOLD NATURAL (HAND SANITIZER GEL) GEL [MY PERFUME FACTORY LLC]2Legacy NDC, 10 package rows20200529_a611188f-90f7-0cd0-e053-2995a90a9a55.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78068-12378068-123-50, 78068-123-60, 78068-123-61, 78068-123-70, 78068-123-10, 78068-123-12, 78068-123-25, 78068-123-05, 78068-123-01, 78068-123-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
a6b1ae32-c308-433c-e053-2995a90a4584a611188f-90f7-0cd0-e053-2995a90a9a552020-05-28WarningsExact identifier
spl id: a6b1ae32-c308-433c-e053-2995a90a4584
spl set id: a611188f-90f7-0cd0-e053-2995a90a9a55

Reported adverse events (FAERS/openFDA)#

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