DIPHENHYDRAMINE - diphenhydramine hydrochloride, zinc acetate cream 
Physicians Total Care, 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.

----------

Active ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

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 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

Other information

Inactive ingredients

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

Questions or comments?

1-800-616-2471

Principal Display Panel

Diphenhydramine Hydrochloride 2%

Cream

28 g

NDC 54868-0113-0


image of package label


Extra Strength

Anti-Itch Cream

Topical Analgesic/Skin Protectant





Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146
DIPHENHYDRAMINE 
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0113(NDC:0904-5354)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE0.1 g  in 100 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:54868-0113-01 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/23/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 6/2012
Document Id: 3a858a9c-77ae-4466-b31c-fff11fa7d469
Set id: 82e6a91c-fb8b-42b5-8b01-3db180b9d7fc
Version: 1
Effective Time: 20120605
 
Physicians Total Care, Inc.