Label: CAMPHOR- SYNTHETIC AND PHENOL gel
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated February 16, 2011
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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
- 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
Store at room temperature. Avoid excessive heat.
Close cover tightly after each use
- INACTIVE INGREDIENT
- 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