Your browser does not support JavaScript! BOROLEUM FOR NASAL SORENESS (CAMPHOR, MENTHOL, WHITE PETROLATUM) OINTMENT [SUMMIT INDUSTRIES]
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RxNorm Names

BOROLEUM FOR NASAL SORENESS (camphor, menthol, white petrolatum) ointment
[Summit Industries]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph 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

Camphor 1%

Menthol 0.54%

White Petrolatum 97.92%

Purpose

External analgesic, skin protectant

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations (e.g. dry nasal passages).

temporarily protects minor cuts, scrapes, burns

helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin

helps prevent and protect from the drying effects of wind and cold weather.

Warnings:

For external use only

Avoid contact with eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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: consult a doctor.

Other information

Store at room temperature.

Inactive ingredients

Eucalyptol, methyl salicylate

Images of Carton and Label

boroleum_pdp.jpg
Boroleum PDP
boroleum_panel.jpg
Boroleum Panel
boroleum_tube.jpg
Boroleum Label
BOROLEUM  FOR NASAL SORENESS
camphor, menthol, white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:12090-1235
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)10 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL5.4 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM979.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE 
EUCALYPTOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12090-1235-01 in 1 BOX
1NDC:12090-1235-117 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/10/2010
Labeler - Summit Industries (003279189)
Registrant - Summit Industries (003279189)
Establishment
NameAddressID/FEIBusiness Operations
Summit Industries003279189manufacture(12090-1235)

Revised: 1/2013
 
Summit Industries

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