Publix Allergy (Diphenhydramine Hydrochloride And Zinc Acetate) Cream [Publix Super Markets Inc] -

PUBLIX ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [PUBLIX SUPER MARKETS INC]
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NDC	41415-046-75
Set ID	746fd004-9567-4b9f-82e3-40855c7354a9
Category	HUMAN OTC DRUG LABEL
Packager	Publix Super Markets Inc
Generic Name
Product Class
Product Number
Application Number	PART348

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients Purpose
Diphenhydramine hydrochloride 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
Uses
- temporarily relieves pain and itching associated with:
  - insect bites
  - minor burns
  - sunburn
  - minor skin irritations
  - minor cuts
  - scrapes
  - rashes due to poison ivy, poison oak, and poison sumac
- dries the oozing and weeping of poison ivy, poison oak, and 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 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
- do not use more often 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
Other information
- To open: unscrew cap, use pointed end of cap to puncture seal.
- store at room temperature
- see carton or tube crimp for lot number and expiration date
Inactive ingredients

cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water
SPL UNCLASSIFIED SECTION

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)

Active ingredients	Purpose
Diphenhydramine hydrochloride 2%	Topical analgesic
Zinc acetate 0.1%	Skin protectant

INGREDIENTS AND APPEARANCE

PUBLIX ALLERGY
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41415-046
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M)	diphenhydramine hydrochloride	20 mg in 1 g
zinc acetate (UNII: FM5526K07A) (zinc cation - UNII:13S1S8SF37)	zinc acetate	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41415-046-75	1 in 1 CARTON	09/20/2005
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/20/2005

Labeler - Publix Super Markets Inc (006922009)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(41415-046)

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Medic

PUBLIX ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [PUBLIX SUPER MARKETS INC]

Do not use

Ask a doctor before use

When using this product

Stop use and ask a doctor if

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