Your browser does not support JavaScript! ANTI ITCH CREAM (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEOPHARM CO., LTD.]
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ANTI ITCH CREAM (diphenhydramine hcl, zinc acetate) cream
[NeoPharm Co., Ltd.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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 Creamimage of a carton label

ANTI ITCH CREAM 
diphenhydramine hcl, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51141-0054
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (ZINC) ZINC ACETATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
CETYL ALCOHOL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PARAFFIN 
METHYLPARABEN 
GLYCERYL MONOSTEARATE 
STEARIC ACID 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0054-21 in 1 BOX
157 g in 1 TUBE
2NDC:51141-0054-11 in 1 BOX
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33609/07/2010
Labeler - NeoPharm Co., Ltd. (631101883)
Registrant - NeoPharm Co., Ltd. (631101883)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture

Revised: 8/2010
 
NeoPharm Co., Ltd.

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