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CVS Fragrance Free Anti-Itch by CVS Pharmacy

Dosage form: lotion
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1mL
Labeler: CVS Pharmacy
NDC Code: 59779-052

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

Pramoxine Hydrochloride...................................External Analgesic




Uses


For the temporary relief of itching associated with minor skin irritations


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 associated with minor skin irritations

Warnings

For external use only

When using this product

- avoid contact with eyes

Stop use and ask a doctor if
- condition worsens
- 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

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

- consult a doctor


Inactive Ingredients

water, isopropyl myristate, stearic acid, glyceryl stearate, PEG-100 stearate, cetyl alcohol,
PEG-8, petrolatum, dimethicone, benzyl alcohol, carbomer, sodium hydroxide




CVS FRAGRANCE FREE ANTI-ITCH 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-052
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER HOMOPOLYMER TYPE C 
ISOPROPYL MYRISTATE 
GLYCERYL MONOSTEARATE 
STEARIC ACID 
CETYL ALCOHOL 
PETROLATUM 
DIMETHICONE 350 
POLYETHYLENE GLYCOL 400 
BENZYL ALCOHOL 
SODIUM HYDROXIDE 
POLYETHYLENE GLYCOL 4500 
Packaging
#Item CodePackage Description
1NDC:59779-052-5880 mL in 1 BOTTLE, PUMP
2NDC:59779-052-59222 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 07/2010
 
CVS Pharmacy

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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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