FDA.reportPublic FDA data

Bite and Itch Lotion

Manufacturer
Weeks & Leo Co., Inc.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:19

Label at a glance#

ProductBite and Itch
Active ingredientPRAMOXINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Diphenhydramine HCl 2%

Pramoxine HCl 1%

OTC - PURPOSE SECTION

Purposes

Topical analgesic

Topical analgesic

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves pain and itching due to:

  • scrapes
  • sunburn
  • minor cuts
  • minor burns
  • insect bites
  • minor skin irritations
  • poison ivy, poison oak, or poison sumac

INSTRUCTIONS FOR USE SECTION

Directions

  • do not use more often than directed
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor

WARNINGS SECTION

Warnings

For external use only

Do not use

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

Ask a doctor before use if you have

  • chicken pox
  • measles

When using this product do not get into eyes

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last 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.

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • chicken pox
  • measles

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • conditions get worse
  • symptoms last for more than 7 days or clear up and occur again within 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.

OTHER SAFETY INFORMATION

Other information

  • store at controlled room temperature
  • call (515) 276-1586 to report any side effects that may occur

INACTIVE INGREDIENT SECTION

Inactive ingredients

cetyl alcohol, diazolidinyl urea, glyceryl stearate, isopropyl myristate, menthol, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use more often than directed
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor

RECENT MAJOR CHANGES SECTION

Added Dosage and Administration section

Updated Warnings section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelBite and Itch

Lotion

Pramoxine HCl 1%

Topical Anesthetic

Diphenhydramine HCl 2%

Antihistamine

Pain Relieving Lotion

4 Fl Oz (118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1292321diphenhydrAMINE HCl 2 % / pramoxine HCl 1 % Topical LotionPSN3
1292321diphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD3
1292321diphenhydramine hydrochloride 2 % / pramoxine hydrochloride 1 % Topical LotionSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11383-192-01Bite and Itch118 mL in 1 BOTTLELOTION1183
11383-192-01Bite and Itch1 in 1 CARTONLOTION13
11383-192-04Bite and Itch118 mL in 1 BOTTLELOTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11383-192BITE AND ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE) LOTION [WEEKS & LEO CO., INC.]3Current NDC, 3 package rows20241206_0a4d471b-c3f3-0a6a-e063-6394a90ad57b.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11383-19211383-192-04, 11383-192-01

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
STEARYL ALCOHOL2KR89I4H1YIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
PEG-40 GLYCERYL STEARATE0A0VSM3HADIACT
CETYL ALCOHOL936JST6JCNIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLPARABENZ8IX2SC1OHIACT

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
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
ndc (package): 11383-192-01
ndc (package): 11383-192-04
ndc (product): 11383-192
ndc11 (package): 11383019204
ndc11 (package): 11383019201
spl id: 28650b5a-ed6f-199c-e063-6394a90a9dac
spl set id: 0a4d471b-c3f3-0a6a-e063-6394a90ad57b

Reported adverse events (FAERS/openFDA)#

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