Dermagesic

Dosage form: liquid
Ingredients: PHENOL 1.4mg in 100mL, DIPHENHYDRAMINE HYDROCHLORIDE 1mg in 100mL
Labeler: Llorens Pharmaceuticals International Division
NDC Code: 54859-201

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.

Drug Facts

Active Ingredients                   Purpose

Phenol.......................... 1.4%.........Analgesic/Anesthetic

Diphenhydramine HCl........ 1%........ Antihistaminic

Uses

  • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritations
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

  • For external use only. Avoid contact with the eyes
  • Not for Pediatric use
  • Hypersensitivity to "caine" anesthetics

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Ask a doctor before use
  • on chicken pox
  • on measles
Stop use and ask a doctor if condition worsens or does not improve within 7 days
  • 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.

Directions  SHAKE WELL

  • Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age ask a doctor
  • Do not use more often than directed

Other Information

  • Store at 59 to 77 degrees fahrenheit
  • Tamper evident by heat seal under cap
  • Do not use if there is evidence of tampering

Inactive Ingredients:Benzocaine, Carbomer, D and C Red No. 33, Eucalyptus Oil, Glycerin, Iropropyl Alcohol, Propylene Glycol, Purified Water, Simethicone and Witch Hazel.

Questions:  1-866-595-5598

DERMAGESIC 
phenol, diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.4 mg  in 100 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZOCAINE 
CARBOMER 1342 
D&C RED NO. 33 
EUCALYPTUS OIL 
GLYCERIN 
WATER 
SILICON DIOXIDE 
WITCH HAZEL 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:54859-201-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33602/01/2009
Labeler - Llorens Pharmaceuticals International Division (037342305)

Revised: 04/2012
 
Llorens Pharmaceuticals International Division

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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