CVS FRAGRANCE FREE ANTI-ITCH - pramoxine hydrochloride lotion 
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

Pramoxine Hydrochloride 1%............................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

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

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CVS FRAGRANCE FREE ANTI-ITCH 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0405
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0405-9222 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/2010
Labeler - RITE AID CORPORATION (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: 39d50907-350c-4068-b4cd-a1d55522fad8
Set id: e5c97707-6a4b-47a9-a371-96245a4d143a
Version: 1
Effective Time: 20100708
 
RITE AID CORPORATION