A HEALTH ITCH RELIEF GEL- itch relief gel gel

A Health Itch Relief Gel by

Drug Labeling and Warnings

A Health Itch Relief Gel by is a Otc medication manufactured, distributed, or labeled by Bionpharma, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Diphenhydramine HCl 2%

Purpose

External analgesic

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

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

on chicken pox measles

When using this product

avoid contact with eyes

Stop use and ask a doctor if

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

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

Directions

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

Camphor, Citric Acid, Diazolidnyl Urea,

Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene

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

Questions and comments?

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

† 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

INGREDIENTS AND APPEARANCE

A HEALTH ITCH RELIEF GEL 
itch relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-496
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-496-55	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/20/2025

Labeler - Bionpharma, Inc. (079637826)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	label(69452-496) , pack(69452-496) , analysis(69452-496) , manufacture(69452-496)