CVS EXTRA STRENGTH ITCH RELIEF - diphenhydramine hydrochloride and zinc acetate ointment 
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.

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DRUG FACTS

Active ingredient                                 Purpose

Diphenhydramine hydrochloride 2%...................Topical Analgesic
Zinc acetate....................................................Skin protectant




Uses


- for the temporary relief of itching and pain 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
 
 


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



Uses

- for the temporary relief of itching and pain 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 or with any other product containing diphenhydramine,
even one taken by mouth

Ask a doctor before use on chicken pox or 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,
or symptoms persist for ore 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

adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor

children under 2 years of age: consult a doctor

Other information

- store at 20 degrees - 25 degrees C (68 to 70 degrees F) - Lot No. and Exp. Date, see crimp of tube or see box
 

Inactive Ingredients

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


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CVS EXTRA STRENGTH ITCH RELIEF 
diphenhydramine hydrochloride and zinc acetate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-053
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 - UNII:J41CSQ7QDS) ZINC ACETATE12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARETH-2 (UNII: V56DFE46J5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARETH-100 (UNII: 4OH5W9UM87)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-053-031 in 1 CARTON
128 g in 1 TUBE
2NDC:59779-053-111 in 1 CARTON
214 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/13/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 9/2010
Document Id: 06fe2623-5c94-44f5-be30-57ec400e8a34
Set id: 6e4b5480-b363-415e-b28d-4a02bd9e194c
Version: 2
Effective Time: 20100913
 
CVS Pharmacy