ANTI-ITCH EXTRA STRENGTH- diphenhydramine hydrochloride, zinc acetate cream 
Personal Care Products, Inc.

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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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:


Dries the oozing and weeping of

Warnings

For external use only

Do not use:


Ask a doctor before use


When using this product avoid contact with the eyes

Stop use and ask a doctor if

Directions

Other information

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


PC AntiItch1 Label

PC AntiItch2 Label

ANTI-ITCH  EXTRA STRENGTH
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2437
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE700 mg  in 35 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION35 mg  in 35 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-2 STEARATE (UNII: 94YQ11Y95F)  
PEG-20 STEARATE (UNII: NBX892EA57)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2437)

Revised: 7/2013
Document Id: 69bf5fe2-9930-4fbb-a2d0-6a61f46dbfbf
Set id: bfa57f40-a1f4-4b53-95d5-1d6d6ed0233f
Version: 1
Effective Time: 20130711
 
Personal Care Products, Inc.