CVS MEDICATED ANTI-ITCH  - menthol, pramoxine hydrochloride cream 
CVS Pharmacy

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

Menthol 1%....................................................Anti-Itch Pain Relief
Pramoxine Hydrochloride 1%............................Anti-Itch Pain Relief



Uses


For the temporary relief of pain and discomfort cause by
- minor burns - sunburn - scrapes - insect bites
- minor skin irritations - rashes due to poison ivy, oak and sumac


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 pain and discomfort cause by
- minor burns - sunburn - scrapes - insect bites
- minor skin irritations - rashes due to poison ivy, oak and sumac

Warnings

For external use only

Do Not use
- under bandages or compresses

When using this product

- avoid contact with the eyes

Stop use and ask a doctor if condition worsens, or if 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 2 tim

- Children under 2 years of age:
do not use, consult a doctor


Inactive Ingredients

Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Gel, Sodium Acrylates Copolymer, Mineral Oil, Steareth 21, PPG 1 Trideceth, 6, Toco[heryl Acetate, Disodium EDTA, Methyl Salicylate, Thymol, Eucalyptol, Triethanolamine, Iodopropynyl Butylcarbamate, Diozolidinyl Urea


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CVS MEDICATED ANTI-ITCH  
menthol, pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-621
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARETH-2 (UNII: V56DFE46J5)  
THYMOL (UNII: 3J50XA376E)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
TROLAMINE (UNII: 9O3K93S3TK)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-621-641 in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/08/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: c3d98a66-fe5d-4989-801b-31e58c563095
Set id: 01447a2d-3a6a-4947-80cf-570b0a2941dd
Version: 1
Effective Time: 20100708
 
CVS Pharmacy