EXTRA STRENGTH FIRST AID ANTI-ITCH RITE AID PHARMACY- diphenhydramine hcl 2% gel 
Rite Aid

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 HCI 2%................Topical analgesic

Uses Temporarily relieves pain due to: • minor burns • insect bites • sunburn • minor skin irritations • minor cuts • scrapes • rashes due to poison ivy, poison oak & 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
When using this product • avoid contact with the eyes
Stop use and ask doctor if • condition gets worse • symptoms last more than 7 days • symptoms clear up and occur again in 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 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.

Inactive ingredients

Camphor, Citric Acid, Diazolidinyl
Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben,
Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium
Citrate, Water.

image description

EXTRA STRENGTH FIRST AID ANTI-ITCH  RITE AID PHARMACY
diphenhydramine hcl 2% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7797
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Glycerin (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
ALCOHOL (UNII: 3K9958V90M)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-7797-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/2013
Labeler - Rite Aid (014578892)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(11822-7797) , label(11822-7797)

Revised: 1/2017
Document Id: 41efb43b-576e-4e7c-9fb4-e61d5a6d2fd5
Set id: f0a4598e-df39-4f0a-9c52-98af58b9718a
Version: 1
Effective Time: 20170120
 
Rite Aid