ATOPALM ITCH RELIEF- diphenhydramine hydrochloride, zinc acetate cream

Atopalm Itch Relief by

Drug Labeling and Warnings

Atopalm Itch Relief by is a Otc medication manufactured, distributed, or labeled by Neopharm Co, Ltd, NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Diphenhydramine HCl 2%

Zinc Acetate 0.1%

Purpose

Topical Analgesic

Skin protectant

Uses

For the temporary relief of itching and pain 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.

Do not use

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

Ask a doctor before use on chicken pox or measles.

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens or does not improve within 7 days, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

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

Directions

adults and children 2 years of age and older, apply to affected area no more than 3 to 4 times daily, or as directed by a doctor.
children under 2 years of age, consult a doctor.
do not use more often than directed

Other information

store between 20C to 25C (69F to 77F)
see end of carton or tube crimp for lot number and expiration date.

Inactive Ingredients

Water, Glycerin, Cetyl Alcohol, Mineral Oil, Polysorbate 60, Stearic Acid, Glyceryl sterate, Carbomer 940, Cholesterol, Methylparaben, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, propylparaben.

Questions?

Call 1-855-ATOPALM

PRINCIPAL DISPLAY PANEL

ATOPALM ITCH RELIEF CREAM

with US Patented MLE Technology

MAXIMUM STRENGTH THERAPY
TOPICAL ANALGESIC

HISTAMINE BLOCKER
SKIN PROTECTANT

For fast, temporary relief of pain and itching from insect bites and skin irritations from poison ivy, poison oak, and poison sumac, dries up poison ivy, poison oak, and poison sumac. Leaves skin looking visibly healthier, softer, smoother.

ATOPALM
Histamine Blocker
Topical Analgesic
Skin protectant

Net Wt. 1oz/28.3 g

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOPALM ITCH RELIEF  
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-4000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
METHYLPARABEN (UNII: A2I8C7HI9T)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-4000-1	1 in 1 BOX
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 final	part347	03/16/2011

Labeler - Neopharm Co, Ltd (965502912)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture(51141-4000)