CVS EXTRA STRENGTH ITCH RELIEF- diphenhydramine hydrochloride and zinc acetate spray 
CVS Pharmacy

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.

----------

DRUG FACTS

Active ingredient                                                               Purpose

Diphenhydramine HCL 2% ...................................................................Topical analgesic
Zinc Acetate 0.1%...............................................................................Skin Protectant



Uses


Temporarily relieves itching and pain associated with minor irritations, burns,
scrapes, cuts, insect bites and rashes due to poison ivy, poison oak and poison
sumac. Dries the oozing and weeping of poison ivy, poison oak and poison sumac.



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


Uses

Temporarily relieves itching and pain associated with minor irritations, burns,
scrapes, cuts, insect bites and 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. Flammable. keep away from fire or flame.

Do not use
-  with any other product containing diphenhydramine,
even one taken by mouth. - On large areas of the body

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

- do not use more than directed

- Adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

- Children under 2 years of age:
consult a doctor

Other information

Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

Inactive Ingredients

purified water, SD alcohol 40-B, glycerin, povidone, tromethamine


c



CVS  EXTRA STRENGTH ITCH RELIEF
diphenhydramine hydrochloride and zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-248
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE (UNII: FZ989GH94E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-248-2559 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/10/2011
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 4/2012
Document Id: 4ce135fa-5afd-4639-bb93-90b7e58859fe
Set id: 04b9fe63-81c8-43ac-ad2d-95574df5c51c
Version: 1
Effective Time: 20120427
 
CVS Pharmacy