CVS SOOTHING ITCH RELIEF - menthol lotion 
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 0.1%..................................................External analgesic lotion



Uses
for the treatment 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 treatment of itching associated with minor skin irritations.

Warnings

For external use only


When using this product
avoid contact with the eyes

Stop use and ask a doctor if
- condition worsens - irritation occurs
- 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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.


Directions

Adults and children 2 years of age and older,

- apply to afected area not more than 3 to 4 times daily

Children under 2 years of age,

- consult a doctor


Inactive Ingredients


acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, caprylic/capric triglyceride,
cetearyl alcohol, cetyl alcohol, colloidal oatmeal, dimethicone, DMDM hydrantoin, glycerin,
glyceryl stearate SE, isopropyl isostearate, myristyl, myristate, octyldodecanol,
oenothera biennis oil (evening primrose), PEG-40 castor oil, phenoxyethanol,
polyglyceryl-3 methylglucose distearate, potassium sorbate, purified water, sodium citrate



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CVS SOOTHING ITCH RELIEF 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 1342 (UNII: 809Y72KV36)  
GLYCERIN (UNII: PDC6A3C0OX)  
OATMEAL (UNII: 8PI54V663Y)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-051-37200 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: d8f0f29b-38db-470e-8960-f8a59a532f70
Set id: 3d57aa25-8819-49fb-95da-2cdd20dc51f1
Version: 1
Effective Time: 20100710
 
CVS Pharmacy