FDA.reportPublic FDA data

The Itch Eraser Max Strength Spray

Manufacturer
Tender Corporation
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:14:50

Label at a glance#

ProductThe Itch Eraser Max Strength
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure6 sections

Indications and uses

​For temporary relief of pain and itching associated with: ​ • insect bites • minor burns • sunburn • minor skin irritations • minor cuts • scrapes • rashes due to poison: ivy, oak and sumac

Dosage and administration

​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 ​: ask a doctor.

Label contents#

Full prescribing information#

​Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

​Purpose:

OTC - PURPOSE SECTION

Topical analgesic

​Uses

INDICATIONS & USAGE SECTION

​For temporary relief of pain and itching associated with:​

• insect bites • minor burns • sunburn • minor skin irritations • minor cuts • scrapes • rashes due to poison: ivy, oak and sumac

​Warnings

WARNINGS SECTION

​For external use only​

• do not get into eyes

​ ​

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use

OTC - ASK DOCTOR SECTION

• on chicken pox • on measles

​Directions

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​: ask a doctor.

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

SD Alcohol 40-2, Purified Water, Povidone, Glycerin, Oat Beta Glucan, Sodium Bicarbonate (Baking Soda), Vitamin E Acetate, Tea Tree Oil, and Zinc Acetate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

outerouterinnerinner

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44224-2410-02020-09-21C16284748780-19d75b9d0-5377-f424-e053-dadaa90a57ceThe Itch Eraser Max Strength Spray
44224-2410-02020-01-31C16284748780-19d75b9d0-5377-f424-e053-dadaa90a57ceThe Itch Eraser Max Strength Spray

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44224-241044224-2410-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POVIDONEFZ989GH94EIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TEA TREE OILVIF565UC2GIACT
ZINC ACETATEFM5526K07AIACT
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
afd7d589-7e32-b8d2-e053-2a95a90a5345c15c19b7-bc1c-4556-9377-12aff93f5e492020-09-21WarningsExact identifier
spl id: afd7d589-7e32-b8d2-e053-2a95a90a5345
spl set id: c15c19b7-bc1c-4556-9377-12aff93f5e49

Reported adverse events (FAERS/openFDA)#

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