CVS Maximum Strength Itch Relief

Dosage form: gel
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 20.5mg in 1mL
Labeler: CVS Pharmacy
NDC Code: 59779-048

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



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, propylene glycol, diazolidinyl urea, hydroxypropyl methylcellolose, camphor, methylparaben, citric acid, sodium citrate, propylparaben




CVS  MAXIMUM STRENGTH ITCH RELIEF
diphenhydramine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-048
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE20.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
ANHYDROUS CITRIC ACID 
CAMPHOR (SYNTHETIC) 
SODIUM CITRATE 
HYPROMELLOSE 2910 (4000 MPA.S) 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:59779-048-69118 mL in 1 BOTTLE, PLASTIC
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/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 04/2012
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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