Boroleum by Santus LLC Boroleum

Boroleum by

Drug Labeling and Warnings

Boroleum by is a Otc medication manufactured, distributed, or labeled by Santus LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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  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	12/12/2019
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	12/12/2019

Labeler - Santus LLC (079868223)

Revised: 1/2020

Document Id: 9d4b60a8-b1a9-0b43-e053-2a95a90ae5ce

34390-5

Set id: 00bd405f-c1c2-402d-bc2e-fa25c8ffaa25

Version: 4

Effective Time: 20200129

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