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Boroleum.com
Boroleum Ointment
FDA Label NDC 69618-052
14 label sections · Submitted to the FDA by Reliable 1 Laboratories · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories for the product Boroleum (NDC 69618-052). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - questions, other, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Other
Drug Facts
Reliable-1 Laboratories LLC Valley Stream NY 11580 Made for Reliable-1 in US
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 and lips
- Helps prevent and protect from the drying effects of wind and cold weather
Warnings
For external use only
Otc - When Using
Avoid contact with eyes.
Otc - Stop Use
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
Otc - Do Not Use
Do not use on:
- deep or puncture wounds
- animal bites
- serious burns
Otc - Keep Out Of Reach Of Children
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 Label.Principal Display Panel
External Analgestic/Skin Protectant
Protects in Dry & Cold Climates
Soothes and Relieves Sore Nose
Moisturizes Dry Nose
Chapped Lip Relief
Use Day or Night
BOROLEUM®
FOR NASAL SORENESS
NDC 69618-052-77
NET WT 0.6 OZ (17G)
* Please review the disclaimer below.
