Your browser does not support JavaScript! BLISTEX LIP (DIMETHICONE, CAMPHOR, MENTHOL, PHENOL) OINTMENT [HART HEALTH]
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BLISTEX LIP (dimethicone, camphor, menthol, phenol) ointment
[HART Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredients:

Dimethicone 1.1% (w/w)

Camphor 0.5% (w/w)

Menthol 0.6% (w/w)

Phenol 0.5% (w/w)

Purpose:

Skin protectant

External analgesic

External analgesic

External analgesic

Uses: for the temporary protection and relief of pain and itching associated with

  • minor lip irritation
  • chapped or cracked lips
  • cold sores

Warnings: For external use only

Do not use

  • in the eyes or over large portions of the body
  • on deep or puncture wounds
  • on animal bites
  • on serious burns

Stop use and ask a doctor if

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms 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. 1-800-222-1222

Directions

Adults and children 2 years of age and over: apply liberally to affected area not more than 3 to 4 times daily

Children under 2 years of age: ask a doctor

Inactive Ingredients: Allontoin, Ammonium Hydroxide, Beeswax, Calcium Disodium EDTA, Calcium Hydroxide, Cetyl Alcohol, Flavors, Glycerin, Lanolin, Lauric Acid, Mineral Oil, Myristic Acid, Oleic Acid, Palmitic Acid, Paraffin, Petrolatum, Polyglyceryl-3 diisostearate, Potassium Hydroxide, Purified Water, SD Alcohol 36, Silica, Sodium Hydroxide, Sodium Saccharin, Stearyl Alcohol

Blistex.jpg

Blistex.jpg

BLISTEX LIP 
dimethicone, camphor, menthol, phenol ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50332-0029
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1.1 g  in 100 g
CAMPHOR OIL (CAMPHOR OIL) CAMPHOR OIL.5 g  in 100 g
MENTHOL (MENTHOL) MENTHOL.6 g  in 100 g
PHENOL (PHENOL) PHENOL.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
EDETATE CALCIUM DISODIUM 
CALCIUM HYDROXIDE 
CETYL ALCOHOL 
GLYCERIN 
LANOLIN 
LAURIC ACID 
MINERAL OIL 
MYRISTIC ACID 
OLEIC ACID 
PALMITIC ACID 
PARAFFIN 
PETROLATUM 
POLYGLYCERYL-3 DIISOSTEARATE 
POTASSIUM HYDROXIDE 
WATER 
SODIUM HYDROXIDE 
STEARYL ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0029-225 in 1 BOX, UNIT-DOSE
1.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/09/1995
Labeler - HART Health (069560969)

Revised: 11/2012
 
HART Health

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