ANTI-ITCH- zinc acetate , diphenhydramine cream

ANTI-ITCH by

Drug Labeling and Warnings

ANTI-ITCH by is a Otc medication manufactured, distributed, or labeled by OL PHARMA TECH, LLC, OL PHARMA TECH, LLC Drs PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

Purpose

Topical analgesic

skin protectant

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

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

When using this product

When using this product avoid contact with eyes

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

KEEP OUT OF REACH OF CHILDREN

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

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 SAFETY INFORMATION

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

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

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

PRINCIPAL DISPLAY PANEL

Itch stopping cream

INGREDIENTS AND APPEARANCE

ANTI-ITCH 
zinc acetate , diphenhydramine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80489-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	1 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DECYL OLEATE (UNII: ZGR06DO97T)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80489-005-01	1 in 1 CARTON	01/01/2021
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2021

Labeler - OL PHARMA TECH, LLC (021170377)

Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)

Establishment
Name	Address	ID/FEI	Business Operations
OL PHARMA TECH, LLC Drs PHARMACY		021170377	manufacture(80489-005)