BOROLEUM FOR NASAL SORENESS- camphor (synthetic), menthol and petrolatum ointment 
Summit Industries

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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Boroleum Drug Facts Label

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:

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

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Boroleum PDP
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Boroleum Panel
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Boroleum Label
BOROLEUM  FOR NASAL SORENESS
camphor, menthol, white petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:12090-1235
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.4 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 979.2 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)  
EUCALYPTOL (UNII: RV6J6604TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12090-1235-0 1 in 1 BOX
1 NDC:12090-1235-1 17 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 12/10/2010
Labeler - Summit Industries (003279189)
Registrant - Summit Industries (003279189)
Establishment
Name Address ID/FEI Business Operations
Summit Industries 003279189 manufacture(12090-1235)

Revised: 1/2013
Document Id: 8c9b0715-099a-4faf-965a-3dde55290322
Set id: 00bd405f-c1c2-402d-bc2e-fa25c8ffaa25
Version: 2
Effective Time: 20130121
 
Summit Industries