Nighttime 4X Medicated Cream

Manufacturer
Rite Aid | Lornamead | Lornamead Products
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:17:31

Label at a glance#

ProductNighttime 4X Medicated Cream
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE, ZINC CHLORIDE, MENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

OTC - PURPOSE SECTION

oral antiseptic

oral pain reliever

oral astringent

INDICATIONS & USAGE SECTION

  • for temporary relief of pain due to toothaches
  • to help protect against infection of minor oral irritation

WARNINGS SECTION

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this produt before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other caine anesthetics.

OTC - DO NOT USE SECTION

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Posion Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
  • allergic reaction occurs

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

cut open tip of tube on score mark

adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor

children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product.

children under 2 years of age: do not use

Do not use:

  • more than directed
  • for more than 7 days unless told do so by a dentist or doctor
  • for teething
  • in children under 2 years of age

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2821632R1 RA Nigthtime toothache and Gum2821632R1 RA Nigthtime toothache and Gum

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamPSN3
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCD3
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011822020138GTIN-13: 0011822020138
EAN-13: 0011822020138
GTIN-12: 011822020138
UPC-A: 011822020138
GTIN storage (14 digits): 00011822020138
2821632R1 RA Nighttime Toothache and gum.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-6300-1Nighttime 4X Medicated Cream7 g in 1 TUBEPASTE73
11822-6300-1Nighttime 4X Medicated Cream1 in 1 CARTONPASTE13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-630011822-6300-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
Nighttime 4X Medicated CreamBENZOCAINERite Aid21645ed1-2dc0-223a-e063-6394a90ab0212025-11-21WarningsExact identifier
ndc (package): 11822-6300-1
ndc (product): 11822-6300
ndc11 (package): 11822630001
spl id: 441ef5c1-674c-f57e-e063-6394a90ab336
spl set id: 21645ed1-2dc0-223a-e063-6394a90ab021

Reported adverse events (FAERS/openFDA)#

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