ANTI-ITCH

Manufacturer: OL PHARMA TECH, LLC | OL PHARMA TECH, LLC Drs PHARMACY
Effective date: 2025-01-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:52:14

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%

Purpose

Topical analgesic skin protectant

Uses

uses

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

Warnings

warnings

For external use only

Ask a doctor before use

on chicken pox on measles

Do Not Use

on large areas of the body with any other product containing diphenhydramine, even one taken by mouth

Stop use and ask a doctor if

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

Directions And Dosage

Directions

Do not use more 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

Directions

do not use more 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

Other Label Information

Inactive Ingredients

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

Questions

drspharmacyusa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Itch stopping cream

Label Images#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1292313	diphenhydrAMINE HCl 1 % / zinc acetate 0.1 % Topical Cream	PSN	4
1292313	diphenhydramine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	4
1292313	diphenhydramine hydrochloride 1 % / zinc acetate 0.1 % Topical Cream	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
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
80489-005-01	ANTI-ITCH	28.3 g in 1 TUBE	CREAM	28.3		4
80489-005-01	ANTI-ITCH	1 in 1 CARTON	CREAM	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80489-005	ANTI-ITCH (ZINC ACETATE , DIPHENHYDRAMINE) CREAM [OL PHARMA TECH, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250112_b79d3096-c609-e710-e053-2995a90a8da2.zip

Products#

ANTI-ITCH
ZINC ACETATE , DIPHENHYDRAMINE
DIPHENHYDRAMINE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80489-005	80489-005-01

Ingredients#

Name, UNII, Kind table
Name	UNII	Kind
DECYL OLEATE	ZGR06DO97T	IACT
TROLAMINE	9O3K93S3TK	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
WATER	059QF0KO0R	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
ZINC ACETATE	FM5526K07A	ACTIM
MINERAL OIL	T5L8T28FGP	IACT
SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
STEARIC ACID	4ELV7Z65AP	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT

Complete SPL Sections#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Topical analgesic skin protectant

uses

INDICATIONS & USAGE SECTION

warnings

WARNINGS SECTION

For external use only

Ask a doctor before use

OTC - ASK DOCTOR SECTION

on chicken pox on measles

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

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not use more 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

OTHER SAFETY INFORMATION

protect from excessive heat (40°C/104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

Questions

OTC - QUESTIONS SECTION

drspharmacyusa.com

Directions

DOSAGE & ADMINISTRATION SECTION

do not use more 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Itch stopping cream

Source Document#

Source XML