ITCH RELIF CVS- diphenhydramine hydrochloride gel 
CVS

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

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.

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 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.

Inactive ingredients:


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

image description

ITCH RELIF  CVS
diphenhydramine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-038
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
ALCOHOL (UNII: 3K9958V90M)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Glycerin (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-038-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/14/2014
Labeler - CVS (062312574)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(69842-038) , label(69842-038)

Revised: 12/2017
Document Id: 047a7a0f-e340-4230-9929-90ddfdf64491
Set id: 8ead8d43-2757-4937-b21d-94395990c371
Version: 2
Effective Time: 20171204
 
CVS