RITE AID MAXIMUM STRENGTH ITCH RELIEF- diphenhydramine hydrochloride and zinc acetate spray 
RITE AID CORPORATION

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



Uses


Temporarily relieves pain and itching associated with
- minor burns - insect bites - sunburn - minor skin irritations
- minor cuts - scrapes - rashes due to 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 pain and itching associated with
- minor burns - insect bites - sunburn - minor skin irritations
- minor cuts - scrapes - rashes due to 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 the eyes

Stop use and ask a doctor if condition worsens,
or if the 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:
ask 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


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RITE AID  MAXIMUM STRENGTH ITCH RELIEF
diphenhydramine hydrochloride and zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0371
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:11822-0371-159 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/10/2011
Labeler - RITE AID CORPORATION (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 4/2012
Document Id: e1af9632-965f-49a2-9412-deb6e16bd31f
Set id: 44b262c6-5c93-4746-a5d8-7ceaf08b8cb1
Version: 4
Effective Time: 20120427
 
RITE AID CORPORATION