CAMPHOR- SYNTHETIC AND PHENOL gel

CAMPHOR (SYNTHETIC) and PHENOL by

Drug Labeling and Warnings

CAMPHOR (SYNTHETIC) and PHENOL by is a Otc medication manufactured, distributed, or labeled by CVS, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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 REACH OF CHILDREN

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.

INDICATIONS & USAGE

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

WARNINGS

Warnings
For external use only.
______________________________________________________________________________

Do not use
- over large areas of the body - with a bandage
______________________________________________________________________________

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAMPHOR (SYNTHETIC) AND PHENOL 
camphor (synthetic) and phenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	108 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	47 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-088-43	6.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	05/19/2009

Labeler - CVS (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture