CAMPHOR (SYNTHETIC) AND PHENOL - camphor (synthetic) and phenol gel 
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
Camphorated phenol (camphor 10.8% and phenoll 4.7%) .........................Pain reliever/antiseptic

Active ingredient                                                                              Purpose
Camphorated phenol (camphor 10.8% and phenoll 4.7%) .........................Pain reliever/antiseptic

Use
- for the temporary relief of pain and itching associated with cold sores and fever blisters
- first aid to help prevent infection


Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control
Center right away.

Do not induce vomiting before contacting medical help or a Poison Control Center.

Uses
- for the temporary relief of pain and itching associated with cold sores and fever blisters
- first aid to help prevent infection

Warnings
For external use only.
______________________________________________________________________________

Do not use
- over large areas of the body - with a bandage
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Ask a doctor before use if you have
- a deep puncture wound - animal bites - serious burns

______________________________________________________________________________

When using this product do not use in or near the eyes. If contact occurs rinse eyes
thoroughly with water and obtain medical attention.
______________________________________________________________________________

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.
Do not induce vomiting before contacting medical help or a Poison Control Center


Directions
- adults and children two years and over:
 - clean the affected area
- apply directly to teh cold sore or fever blister 1 to 3 times daily
- Do not bandage

Children under two years: ask a doctor
 
Other information

Store at room temperature. Avoid excessive heat.
Close cover tightly after each use

Inactive Ingredients colloided silicon dioxide, eucalyptus oil, glycerin, light mineral oil


label

CAMPHOR (SYNTHETIC) AND PHENOL 
camphor (synthetic) and phenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-088
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)108 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL47 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-088-436.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34805/19/2009
Labeler - CVS (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: 4c3f3bbf-4bc8-4637-afdb-338d3817e878
Set id: c6459570-e458-47e5-aa01-fdf34f349adc
Version: 2
Effective Time: 20110216
 
CVS