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Anti-Itch by Universal Distribution Center LLC

Medically reviewed on April 16, 2018

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 0.02g in 1g, ZINC ACETATE 0.001g in 1g
Labeler: Universal Distribution Center LLC
NDC Code: 52000-023

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.

Anti-Itch Cream

Active Ingredients

Diphenhydramine Hydrochloride  2%

Zinc Acetate  0.1%

Purpose

Topical Analgesic

Skin Protectant

Uses

For the temporary relief of pain and itching associated with:

  • minor skin irritation
  • allergic itches
  • rashes
  • hives
  • minor burns
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac

Warnings

Do not use on children under 2 years of age.

For external use only

  • avoid contact with eyes
  • do not apply to open wound or damaged skin.

Stop use and ask a doctor

  • if condition worsens
  • symptoms persist for 7 days or clear up and occur again within a few days.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

  • For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

  • For children under 2 years of age: consult a physician.

Other information

  • Store at 20ºC to 25ºC (68ºF to 77ºF).

Inactive ingredients

Cetyl Alcohol, Diazolidinly urea, Methylparaben, Polyethylene Glycol Monostearate 1000, Propylene Gylcol, Propylparaben, Aloevera extract, Alpha-Tocopherol Acetate, Purified Water.

PRINCIPAL DISPLAY PANEL

Anti-Itch Cream

NET WT 1 OZ (28 g)

ANTI-ITCH 
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE0.02 g  in 1 g
ZINC ACETATE (ZINC CATION) ZINC CATION0.001 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL 
WATER 
CETYL ALCOHOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PEG-20 STEARATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:52000-023-371 TUBE in 1 BOX
1NDC:52000-023-3928 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2015
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-023)

 
Universal Distribution Center LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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