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Anti-Itch Extra Strength by Personal Care Products, Inc.

Medically reviewed on July 11, 2018

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 700mg in 35g, ZINC ACETATE 35mg in 35g
Labeler: Personal Care Products, Inc.
NDC Code: 29500-2437

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.

Active ingredients

Drug Facts

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

For the temporary relief from pain and itching associated with:

  • insect bites
  • sunburn
  • minor skin irritations
  • minor burns
  • scrapes


Dries the oozing and weeping of

  • poison ivy
  • poison oak
  • poison sumac

Warnings

For external use only

Do not use:

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth


Ask a doctor before use

  • on chicken pox
  • on 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
  • symptoms persist for more than 7 day or clear up and occur again within a few days

Directions
  • do not use more than directed
  • adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • use daily for 4 weeks

Other information
  • store at temperature between 58° - 77° F  (15° - 30° C)
  • do not use if seal on tube is punctured or missing

Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene gylcol, propylparaben, purified water

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Extra Strength

Anti-Itch Cream


Topical Analgesic and Skin Protectant


Histamine Blocker

Relieves itching from

    * Poison ivy
    * Poison sumac
    * Sunburn
    * Insect bites


NET WT. 1.25 OZ.  (35 g)

DRUGSTORE-Rx

SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item. That's smart wellness!

Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 48084 U.S.A.

Code No. MH/DRUGS/KD-313               Made in India


ANTI-ITCH  EXTRA STRENGTH
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2437
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE700 mg  in 35 g
ZINC ACETATE (ZINC CATION) ZINC CATION35 mg  in 35 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PEG-2 STEARATE 
PEG-20 STEARATE 
PROPYLENE GLYCOL 
PROPYLPARABEN  
WATER 
Packaging
#Item CodePackage Description
1NDC:29500-2437-135 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2013
Labeler - Personal Care Products, Inc. (966155082)
Registrant - Personal Care Products, Inc. (966155082)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2437)

 
Personal Care Products, Inc.

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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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