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

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

Package Labeling

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
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
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12090-1235-1 17 g in 1 TUBE; Type 0: Not a Combination Product 12/10/2010 12/10/2010
2 NDC:12090-1235-0 1 in 1 BOX 12/10/2010
2 17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/10/2010
Labeler - Santus LLC (079868223)

Revised: 2/2017
Document Id: 47f174e6-641e-5105-e054-00144ff88e88
Set id: 00bd405f-c1c2-402d-bc2e-fa25c8ffaa25
Version: 3
Effective Time: 20170207
 
Santus LLC