SHOPKO CAMPHOR PHENOL GEL- camphor, phenol gel 
Shopko

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

Camphor 10.8%, Phenol 4.7%

Purpose

Pain Reliever/Antiseptic

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately. 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 or with a bandage. Ask a doctor before use if you have a deep puncture wound, animal bites, or serious burns.

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

Stop use and consult a doctor if: conditions worsen or symptoms persist more than 7 days, or clears up and returns again in a few days.

Directions

Directions

Adults and children over 2 years clean the affected area and apply directly to a cold sore or fever blister 1 to 3 times daily. Do not bandage. Children under 2 years: ask a doctor.

Inactive Ingredients

Eucalyptus Globulus Leaf Oil, Glycerin, Mineral Oil, Silica

Package/Label Principal Display Panel

Front of Box of Shopko Medicated Cold Sore Treatment
SHOPKO CAMPHOR PHENOL GEL 
camphor, phenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-734
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10.8 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL4.7 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP) 77.75 mg  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 5.75 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mg  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) 0.500 mg  in 1 g
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-734-041 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/15/2013
Labeler - Shopko (023252638)
Registrant - Shopko (023252638)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(37012-734) , LABEL(37012-734)

Revised: 7/2013
Document Id: 8b92923f-8dff-4736-b1fb-35ac03f82bcb
Set id: 8b92923f-8dff-4736-b1fb-35ac03f82bcb
Version: 1
Effective Time: 20130729
 
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