FDA.reportPublic FDA data

Anti-Itch

Manufacturer
Meijer | Product Quest Mfg
Effective date
2018-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:03

Label at a glance#

ProductAnti-Itch
Active ingredientCAMPHOR (SYNTHETIC), Menthol
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                  Purpose
Camphor 0.5%.......................................External Analgesic
Menthol 0.5%.........................................External Analgesic

INDICATIONS & USAGE SECTION

Uses

For temporary relief of pain and itching associated with
• minor burns • sunburn • minor cuts • scrapes • insect bites
• minor skin irritations

WARNINGS SECTION

Warnings
For external use only
When using this product • Avoid contact with the eyes.
Stop use and ask a doctor if • Condition worsens • Symptoms persist
for more than 7 days or clear up and occur again within a few days.
Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions • Adults and children 2 years of age and older: Apply to
affected area not more than 3 to 4 times daily. • Children under 2 years
of age: Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer
Cetyl Alcohol
DMDM Hydantoin
Fragrance
Glyceryl Stearate
Isopropyl Myristate
PEG-8 Stearate
PEG-100 Stearate
Petrolatum
Sodium Hydroxide
Stearic Acid
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200176camphor 0.5 % / menthol 0.5 % Topical LotionPSN1
200176camphor 5 MG/ML / menthol 5 MG/ML Topical LotionSCD1
200176camphor 0.5 % / menthol 0.5 % Topical LotionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-797-062020-01-31C16284748780-19d75b9d1-0291-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-797-06Anti-Itch222 mL in 1 BOTTLELOTION2221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-797ANTI-ITCH (CAMPHOR 0.5% MENTHOL 0.5%) LOTION [MEIJER]1Legacy NDC, 1 package rows20180622_e31dceb4-468c-465f-82e7-2af4617d9ee0.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-79741250-797-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MentholL7T10EIP3AACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
Cetyl Alcohol936JST6JCNIACT
DMDM HydantoinBYR0546TOWIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
Isopropyl Myristate0RE8K4LNJSIACT
PEG-8 Stearate2P9L47VI5EIACT
PEG-100 StearateYD01N1999RIACT
Petrolatum4T6H12BN9UIACT
Sodium Hydroxide55X04QC32IIACT
Stearic Acid4ELV7Z65APIACT
WATER059QF0KO0RIACT

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
4a463098-6b20-4288-8929-86d1e6bd90efe31dceb4-468c-465f-82e7-2af4617d9ee02018-06-21WarningsExact identifier
spl id: 4a463098-6b20-4288-8929-86d1e6bd90ef
spl set id: e31dceb4-468c-465f-82e7-2af4617d9ee0

Reported adverse events (FAERS/openFDA)#

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