CVS ANTI ITCH - camphor, and menthol lotion 
CVS

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

Camphor 0.5%......................................external analgesic
Menthol 0.5%....................................... external analgesic


Uses
 
for the temporary relief of pain and itching associated with minor skin irritations such as
poison ivy/oak/sumac, sunburn, insect bites and minor cuts and scrapes.


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 itching associated with minor skin irritations such as
poison ivy/oak/sumac, sunburn, insect bites and minor cuts and scrapes.

Warnings

For external use only

When using this product
- avoid contact with the 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 of age and older:

- apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age

- consult a doctor.



Inactive Ingredients


carbomer 940, cetyl alcohol, DMDM hydantion, fragrance, glyceryl stearate,
isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water,
sodium hydroxide, stearic acid

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CVS ANTI ITCH 
camphor, and menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-713
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 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 (UNII: 92RU3N3Y1O)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-713-02222 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 (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: 5b45fde7-ad88-4315-84db-88f27253fbe7
Set id: d7a7d843-bc78-4216-8b2d-06d7f30ac7b1
Version: 1
Effective Time: 20100708
 
CVS