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Name:Boroleum For Nasal Soreness
Manufacturer:Summit Industries
Category:Over-the-counter (OTC) Marketed Drugs


Boroleum 17g

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 17g

Drug Facts

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).

Temporarilyl protects minor cuts, scrapes, burns

helps prevent and temporarily protects and helps relieve changed 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 ingredints

Eucalyptol, methyl salicylate


Sinclair Pharmacal Co., 494 Bridgeport Avenue #389,  Shelton, CT 06484, Made in U.S.A.


Boroleum

For Nasal Soreness


Same great formula

External Analgesic/Skin Protectant

Soothes and relieves sore nose

Moisturizes dry nose

Use in or out of nostrils

Use Day or Night

Trusted Since 1906

Breathe In the Boroleum Difference

www.boroleum.com



Boroleum for Nasal Soreness

Net. Wt. 3/5oz (17g)

Boroleum External Analgesic/Skin protectant
Active ingredients: Camphor 1%, Mentol 0.54%, White Petrolatum 97.92%
Inactive Ingredients: Eucalyptol, Methyl Salicylate
Uses: For the temporary relief of pain and itching associated with minor burns, sunburn, minor scrapes, insect bites, and minor skin irritations (e.g. dry nasal passages.) Temporary protects and helps relieve irritated, chafed. chapped or cracked skin.
WARNINGS: For external use only. Avoid eye contact. Do not apply over deep wounds or lacerations. Keep out of reach of children. Consult a physician if the above conditions persist after 7 days. 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.
Sinclair Pharmacal Co., 494 Bridgeport Avenue #389, Shelton, CT 06484., Made in U.S.A.



Boroleum PDP

Boroleum Drug Panel

Boroleum Tube


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) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 1 g  in 100 g
MENTHOL (MENTHOL) MENTHOL 0.54 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM 97.92 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
EUCALYPTOL  
METHYL SALICYLATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12090-1235-0 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 17 g in 1 TUBE This package is contained within the BOX (12090-1235-0)

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 Operations
Summit Industries 003279189 manufacture

Revised: 12/2010 Summit Industries



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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