Dermachange Aid Anti-Itch Gel, Diphenhydramine HCl 2%

Manufacturer: Private Label Beauty and Wellness | Derma Care Research Labs, LLC
Effective date: 2024-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:09:24

Label at a glance#

ProductDermachange Aid Anti-Itch

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

OTC - PURPOSE SECTION

Topical Analgesic.

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac.

WARNINGS SECTION

For external use only. Do not use on large areas of the body, with any other products containing diphenhydramine, even one taken by mouth. When using this product avoid contact with eyes. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Do not use more than directed. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Camphor, Citric Acid, Ethylhexylglycerin, Glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Propylene Glycol, SD Alcohol 38-B, Sodium Citrate, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049880	diphenhydrAMINE HCl 2 % Topical Gel	PSN	1
1049880	diphenhydramine hydrochloride 0.02 MG/MG Topical Gel	SCD	1
1049880	diphenhydramine hydrochloride 2 % Topical Gel	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83520-107-03	Dermachange Aid Anti-Itch	104 mL in 1 TUBE	GEL	104		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83520-107	DERMACHANGE AID ANTI-ITCH (DIPHENHYDRAMINE HCL) GEL [PRIVATE LABEL BEAUTY AND WELLNESS]	1	Current NDC, 1 package rows	20240307_12ed906c-d028-0ff7-e063-6394a90aaa52.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Dermachange Aid Anti-Itch
Diphenhydramine HCl
CAMPHOR (SYNTHETIC)
HYPROMELLOSES
GLYCERIN
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
ALCOHOL
ETHYLHEXYLGLYCERIN
WATER
CITRIC ACID MONOHYDRATE
PHENOXYETHANOL
PROPYLENE GLYCOL
SODIUM CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83520-107	83520-107-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
GLYCERIN	PDC6A3C0OX	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
ALCOHOL	3K9958V90M	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
WATER	059QF0KO0R	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier ndc (package): 83520-107-03 ndc (product): 83520-107 ndc11 (package): 83520010703 spl id: 12ed906c-d027-0ff7-e063-6394a90aaa52 spl set id: 12ed906c-d028-0ff7-e063-6394a90aaa52

Reported adverse events (FAERS/openFDA)#

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