itch relief

Manufacturer
Bionpharma Inc. | Galentic Pharma (India) Private Limited
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:23

Label at a glance#

Productitch relief
Active ingredientZINC ACETATE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

■ Store at 15° to 30°C (59° to 86°F) ■ Close the cap tightly after use ■ Lot No. & Exp. Date: See box or crimp of tube

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ dries the oozing and weeping of poison ivy, poison oak, and poison sumac

■ temporarily relieves pain and itching associated with:
■ minor cuts ■ sunburn ■ scrapes
■ minor skin irritations ■ minor burns ■ insect bites

■ rashes due to poison ivy, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only.

Do not use

■ with any other product containing diphenhydramine, even one taken by mouth
■ on large areas of the body
■ on broken, blistered, or oozing skin

Ask a doctor before use

OTC - ASK DOCTOR SECTION

■ on measles ■ on chicken pox ■ on poison ivy ■ on sunburn

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens or does not improve within 7 days
■ symptoms persist for 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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ children under 2 years of age: ask a doctor
■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

■ do not use more than directed

Other information

STORAGE AND HANDLING SECTION

■ Store at 15° to 30°C (59° to 86°F) ■ Close the cap tightly after use
■ Lot No. & Exp. Date: See box or crimp of tube

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60,
propylparaben, purified water, stearic acid

SPL UNCLASSIFIED SECTION

READ AND KEEP CARTON FOR COMPLETE INFORMATION

*This product is not manufactured or distributed by the owners of Benadryl® Extra Strength ItchStopping Cream.

Manufactured for: Bionpharma Inc., Princeton, NJ 08540

MADE IN INDIA

GUJ/DRUGS/G/25/2134

L0000814

R0424

LOT & EXP.

tube carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

* compare to the active ingredient in Benadryl® Extra Strength Itch Stopping Cream

NDC 69452-449-37

a+ health TM

itch relief cream
diphenhydramine HCl 2 % + zinc acetate 0.1%

net wt. 1.25 oz

dye-free • phthalate-free • fragrance-free

• extra strength

• topical analgesic

• skin protectant

image001image001

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
69452-449-37itch relief1 in 1 CARTONCREAM11
69452-449-37itch relief35.4 g in 1 TUBECREAM35.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-449ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [BIONPHARMA INC.]1Current NDC, 2 package rows20240718_178ed513-4f22-8f11-e063-6294a90a109b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-44969452-449-37

Ingredients#

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

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

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
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEBionpharma Inc.178ed513-4f22-8f11-e063-6294a90a109b2024-07-16WarningsExact identifier
ndc (package): 69452-449-37
ndc (product): 69452-449
ndc11 (package): 69452044937
spl id: 178ed513-4f23-8f11-e063-6294a90a109b
spl set id: 178ed513-4f22-8f11-e063-6294a90a109b

Reported adverse events (FAERS/openFDA)#

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