PUBLIX  ALLERGY- diphenhydramine hydrochloride and zinc acetate cream 
Publix Super Markets 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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Publix
allergy cream

Drug Facts

Active ingredientsPurpose
Diphenhydramine hydrochloride 2%Topical analgesic
Zinc acetate 0.1%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 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, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 28.4g Tube Carton

EXTRA STRENGTH

Publix

allergycream

2% DIPHENHYDRAMINE HYDROCHLORIDE

• topical analgesic • antihistamine • skin protectant

NET WT 1 OZ (28.4g)

Principal Display Panel - 28.4g Tube Carton
PUBLIX   ALLERGY
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride20 mg  in 1 g
zinc acetate (UNII: FM5526K07A) (zinc cation - UNII:13S1S8SF37) zinc acetate1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
cetyl alcohol (UNII: 936JST6JCN)  
glyceryl monostearate (UNII: 230OU9XXE4)  
PEG-100 stearate (UNII: YD01N1999R)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41415-046-751 in 1 CARTON09/20/2005
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/20/2005
Labeler - Publix Super Markets Inc (006922009)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(41415-046)

Revised: 2/2019
Document Id: 3e050d3c-fd69-4dd1-96c3-0fb477612b54
Set id: 746fd004-9567-4b9f-82e3-40855c7354a9
Version: 3
Effective Time: 20190227
 
Publix Super Markets Inc