CAMPHO-PHENIQUE ANTISEPTIC  GEL- camphor, phenol gel 
Bayer HealthCare LLC.

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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Campho-Phenique Pain Relieving Antiseptic Gel

Drug Facts

Active ingredient

Camphorated phenol (camphor 10.8% and phenol 4.7%)

Purposes

Pain reliever/antiseptic

  • for temporary relief of pain and itching associated with

· minor burns · sunburn · minor cuts

· scrapes · insect bites · minor skin irritation

  • first aid to help protect against infection in

· minor cuts · scrapes · burns

Warnings

For external use only

Do not use

  • over large areas of the body
  • with a bandage
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • a deep or 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.

  • adults and children 2 years and over:
  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • do not bandage
  • children under 2 years: ask a doctor

  • store at room temperature. Avoid excessive heat above 40°C (104°F).
  • close cap tightly after use

colloidal silicon dioxide, eucalyptus oil, glycerin, light mineral oil

Questions or comments? 1-800-986-0369 (Mon - Fri 9AM – 5PM EST)

camphogel

CAMPHO-PHENIQUE ANTISEPTIC   GEL
camphor, phenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL4.7 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0230-041 in 1 CARTON01/26/201511/01/2018
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/26/201511/01/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 10/2017
 
Bayer HealthCare LLC.