61010-8300, Itch Relief Spray

Manufacturer: Safetec of America, Inc.
Effective date: 2024-02-04
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:08:31

Label at a glance#

ProductItch Relief

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

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

Dosage and administration

12 and over: apply to affected area not more than 3 to 4 times daily under 12: consult a doctor

Contacts and useful links#

PhoneLabel contact800-456-7077

Websitewww.safetec.com

www.safetec.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, poison oak and 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 products using diphenhydramine hydrochloride, even one taken by mouth

Ask a doctor before use

OTC - ASK DOCTOR SECTION

on chicken pox
on measles

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

condition worsens
symptoms persist more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenIf swallowed, get medical help or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

12 and over: apply to affected area not more than 3 to 4 times daily
under 12: consult a doctor

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Germaben II, edetate disodium, glycerin, tomadol 25-9, purified water, triethanolamine

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-8300-1

Safetec

Diphenhydramine

Itch Relief Spray

Relief from pain and

itching due to insect

bites and rashes from

poison ivy, poison oak

and poison sumac.

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077

www.safetec.com

2 fl. oz. (59.1ml) Reorder no. 57001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1050080	diphenhydrAMINE HCl 2 % Topical Spray	PSN	3
1050080	diphenhydramine hydrochloride 20 MG/ML Topical Spray	SCD	3
1050080	diphenhydramine HCl 2 % Topical Spray	SY	3

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-8300-1	2024-02-13	C162847	48780-1	1030e365-2119-111a-e063-dadaa90a10e2	61010-8300, Itch Relief Spray
61010-8300-1	2024-01-30	C162847	48780-1	1030e365-2119-111a-e063-dadaa90a10e2	61010-8300, Itch Relief Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-8300-1	Itch Relief	0.0591 L in 1 BOTTLE, SPRAY	LIQUID	0.0591		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-8300	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240214_4f4c801b-d894-4fa3-b024-6ca41a5f2a95.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
diphenhydramine hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	1
diphenhydramine	ACTIVE MOIETY	8GTS82S83M	1
C12-15 PARETH-9	INACTIVE INGREDIENT	H3ZIY6WP1R	1
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Itch Relief
diphenhydramine hydrochloride
DIAZOLIDINYL UREA
EDETATE DISODIUM
GLYCERIN
C12-15 PARETH-9
WATER
TROLAMINE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61010-8300	61010-8300-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
C12-15 PARETH-9	H3ZIY6WP1R	IACT
WATER	059QF0KO0R	IACT
TROLAMINE	9O3K93S3TK	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 38 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii+dosage form 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii+route 28 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii+dosage form 28 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 6 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii+route 28 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii+route 28 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii+dosage form 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+dosage form 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route 28 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii+route 28 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii+dosage form 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii+route 28 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii+route 28 equally ranked IID candidates
diazolidinyl urea	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 6 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii+route 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii+dosage form 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii+route 28 equally ranked IID candidates

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
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Safetec of America, Inc.	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	2024-02-04	Warnings	Exact identifier ndc (package): 61010-8300-1 ndc (product): 61010-8300 ndc11 (package): 61010830001 spl id: 109674e0-ef83-5844-e063-6394a90ae6b8 spl set id: 4f4c801b-d894-4fa3-b024-6ca41a5f2a95

Reported adverse events (FAERS/openFDA)#

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