ANTI ITCH CREAM- diphenhydramine hcl, zinc acetate cream

Anti Itch Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each gram)

Diphenhydramine HCl 2%

Zinc acetate 0.1%

Purposes

Topical analgesic

Skin protectant

Uses

• temporarily relieves itching and pain associated with insect bites, minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
• dries the oozing and weeping of poison ivy, poison oak, and poison sumac
  

Warnings

For external use only

Do not use

• on chicken pox or measles
• with any other product containing diphenhydramine, even one taken by mouth
• on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin
  

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

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

Directions

• adults and children 12 years of age and over:  apply to affected area not more than 3 to 4 times daily
• children under 12 years of age:  ask a doctor
• do not use more often than directed
  

Other information

• store at 59° to 77°F

Inactive ingredients

Carbomer 940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Methylparaben, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Propylparaben, Purified water

Package label

Anti-Itch Cream

INGREDIENTS AND APPEARANCE

ANTI ITCH CREAM 
diphenhydramine hcl, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0054
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 - UNII:J41CSQ7QDS)	ZINC ACETATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0054-2	1 in 1 BOX
1		57 g in 1 TUBE
2	NDC: 51141-0054-1	1 in 1 BOX
2		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	09/07/2010

Labeler - NeoPharm Co., Ltd. (631101883)

Registrant - NeoPharm Co., Ltd. (631101883)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture