BOROLEUM FOR NASAL SORENESS- camphor, menthol, white petrolatum ointment 
Santus 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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Boroleum

Active ingredients

Camphor 1%

Menthol 0.54%

White Petrolatum 97.92%

Purpose

External analgesic

External analgesic

Skin protectant

Uses

  • For the temporary relief of pain and itching associated with minor cuts, scrapes, insect bites, and minor skin irritations (e.g. chafed nose)
  • Temporarily protects minor cuts and scrapes
  • Helps prevent, relieve, and temporarily protect chafed, chapped, or cracked skin

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

Package Labeling

Boroleum label

BOROLEUM  FOR NASAL SORENESS
camphor, menthol, white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12090-1235
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM979.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12090-1235-117 g in 1 TUBE; Type 0: Not a Combination Product12/10/201012/10/2010
2NDC:12090-1235-01 in 1 BOX12/10/201012/12/2019
217 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 finalpart34812/10/201012/12/2019
Labeler - Santus LLC (079868223)

Revised: 1/2020
 
Santus LLC