FDA.reportPublic FDA data

GNP Extra Strength Anti-Itch Cream

Manufacturer
Amerisource Bergen | Weeks & Leo Co., Inc. | Weeks & Leo Co., Inc
Effective date
2025-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:58

Label at a glance#

ProductGNP Extra Strength Anti-Itch Cream
Active ingredientZINC ACETATE, DIPHENHYDRAMINE HCL
Label structure12 sections

Indications and uses

temporarily relieves pain and itching due to: insect bites minor burns sunburns minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak and poison sumac dries the oozing and weeping of poison: Ivy oak sumac

Dosage and administration

do not use more often then directed adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: ask doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Ask Doctor Section

OTC - ASK DOCTOR SECTION

conditions worsen

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

Do not use section

OTC - DO NOT USE SECTION

on chicken pox, poison ivy, sunburn, large areas of the body, broken, blistered, or oozing skin, more often than directed, or with any other product containing diphenhydramine, even one taken by mouth

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

do not use more often then directed

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask doctor

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

  • insect bites
  • minor burns
  • sunburns
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak and poison sumac
  • dries the oozing and weeping of poison:
    • Ivy
    • oak
    • sumac

OTHER SAFETY INFORMATION

Store at 20C to 25C (68F to 77F)

INACTIVE INGREDIENT SECTION

ceytl alcohol

diazolindinyl urea

methlparaben

polyethylene glycol

monostearate 1000

propylene glycol

propylparaben

purified water

stearyl alcohol

OTC - PURPOSE SECTION

Diphenhydramine hydrochloride...............Topical anagesic

Zinc acetate..............................................Skin protectant

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

68-258-51v3.068-258-51v3.0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN1
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD1
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-804-36GNP Extra Strength Anti-Itch Cream1 g in 1 TUBECREAM11
46122-804-36GNP Extra Strength Anti-Itch Cream1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-804-36GM - Gram46122-8042ee9ec29-d2ab-4d4d-a8af-4903dfc1bc3912025-08-11

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
46122-80446122-804-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ZINC ACETATEFM5526K07AACTIB
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HCLTC2D6JAD40ACTIB
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
GNP Extra Strength Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEAmerisource Bergen34a66224-ef3c-e36e-e063-6394a90ac99d2025-05-08WarningsExact identifier
ndc (package): 46122-804-36
ndc (product): 46122-804
ndc11 (package): 46122080436
spl id: 34a66224-ef3d-e36e-e063-6394a90ac99d
spl set id: 34a66224-ef3c-e36e-e063-6394a90ac99d

Reported adverse events (FAERS/openFDA)#

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