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Name:Anti Itch Cream
Manufacturer:Neopharm Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTI ITCH CREAM  - diphenhydramine hydrochloride and zinc acetate cream 
NeoPharm Co., Ltd.

Disclaimer: 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.

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Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:51141-0054
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 2 g  in 100 g
ZINC ACETATE (ZINC) ZINC ACETATE 0.1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C  
CETYL ALCOHOL  
GLYCERIN  
GLYCERYL MONOSTEARATE  
PARAFFIN  
METHYLPARABEN  
GLYCERYL MONOSTEARATE  
STEARIC ACID  
PROPYLPARABEN  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51141-0054-2 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 57 g in 1 TUBE This package is contained within the BOX (51141-0054-2)
2 NDC:51141-0054-1 1 TUBE ( TUBE) in 1 BOX contains a TUBE
2 28 g in 1 TUBE This package is contained within the BOX (51141-0054-1)

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 Operations
NeoPharm Co., Ltd. 631101883 manufacture

Revised: 08/2010 NeoPharm Co., Ltd.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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