A Health Itch Relief Gel

Manufacturer
Bionpharma, Inc. | Pharma Nobis, LLC
Effective date
2025-06-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:35

Label at a glance#

ProductA Health Itch Relief Gel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

Temporarily relieves pain due to: • minor burns • insect bites • sunburn • minor skin irritation • minor cuts • scrapes • rashes due to poison ivy, poison oak & poison 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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

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 & poison sumac

Warnings

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.

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

• 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

Camphor, Citric Acid, Diazolidnyl Urea,

Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene

Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

Questions and comments?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Bionpharma Inc., Princeton, NJ 08540

L0000940 R0125

†This product is not manufactured or distributed by the owner of the registered trademark Benadryl†®

4 fl oz (118 mL) tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

† Compare to the active ingredient

in Benadryl ® Gel

a+ health TM

extra strength

itch

relief

gel

diphenhydramine HCl 2%

topical analgesic

cooling itch relief

for insect bites

& poison ivy/oak/

sumac rashes

4 fl oz (118 mL)

DO NOT USE IF FOIL UNDER CAP IS BROKEN OR MISSING

tube-labeltube-label

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
69452-496-55A Health Itch Relief Gel118 mL in 1 TUBEGEL1181

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
69452-49669452-496-55

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
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.38040732-48c9-3533-e063-6394a90af10a2025-06-20WarningsExact identifier
ndc (package): 69452-496-55
ndc (product): 69452-496
ndc11 (package): 69452049655
spl id: 380409be-9932-3933-e063-6294a90a4e72
spl set id: 38040732-48c9-3533-e063-6394a90af10a

Reported adverse events (FAERS/openFDA)#

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