FDA.reportPublic FDA data

Freskaro Itch Relief Gel

Manufacturer
Pharma Nobis, LLC
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:54

Label at a glance#

ProductA Health Itch Relief Gel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

OTC - PURPOSE SECTION

External Analgesic

INDICATIONS & USAGE SECTION

Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac.

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • measles

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again in a few days

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.

DOSAGE & ADMINISTRATION SECTION

Do not use more often than directed.

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: do not use, consult a doctor.

INACTIVE INGREDIENT SECTION

Camphor, Citric Acid, Diazolidnyl Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

Questions & comments?

OTC - QUESTIONS SECTION

1-833-551-0932

2026 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Itch Relief Gel 2026Freskaro Itch Relief Gel 2026

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130382645116941GTIN-13: 0382645116941
EAN-13: 0382645116941
GTIN-12: 382645116941
UPC-A: 382645116941
GTIN storage (14 digits): 00382645116941		Freskaro Itch Relief Gel 4 15 2026.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-116-94A Health Itch Relief Gel118 mL in 1 BOTTLE, PLASTICGEL1181

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
82645-11682645-116-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
A Health Itch Relief GelITCH RELIEF GELPharma Nobis, LLC4f80c403-c760-31ec-e063-6394a90a61c92026-04-15WarningsExact identifier
ndc (package): 82645-116-94
ndc (product): 82645-116
ndc11 (package): 82645011694
spl id: 4f80c410-155c-9faa-e063-6294a90ac2f3
spl set id: 4f80c403-c760-31ec-e063-6394a90a61c9

Reported adverse events (FAERS/openFDA)#

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