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  5. Label Information: Biocorneum Plus Spf 30 Advanced Scar Supervision

FDA Label for Biocorneum Plus Spf 30 Advanced Scar Supervision

View Indications, Usage & Precautions

Table of Contents

    1. BIOCORNEUM + PLUS SPF 30 ADVANCED SCAR SUPERVISION
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. KEEP OUT OF REACH OF CHILDREN.
    7. OTC - WHEN USING
    8. OTC - DO NOT USE
    9. OTC - STOP USE
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. REPRESENTATIVE LABELING

Biocorneum Plus Spf 30 Advanced Scar Supervision Product Label

The following document was submitted to the FDA by the labeler of this product Enaltus Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Biocorneum + Plus Spf 30 Advanced Scar Supervision





Active Ingredients



Octinoxate 7.5%
Octisalate 5.0%
Octocrylene 10%
Oxybenzone 6.0%


Purpose



Sunscreen


Uses



bioCorneumis a unique scar therapy providing a patented silicone gel to help prevent abnormal scar formation with high protection sunscreen agents.


Warnings



For external use only


Keep Out Of Reach Of Children.





Otc - When Using



Avoid direct contact with eyes, mucous membranes, third degree burns, and open wounds.


Otc - Do Not Use



Should not be used on dermatological conditions that disrupt the integrity of the skin.


Otc - Stop Use



If irritation occurs, discontinue use and consult your physician.


Directions



Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • ensure that the affected area is clean and dry
  • apply evenly in a thin layer twice daily, 15 minutes before sun exposure
  • allow to dry
  • children under 6 months: ask a doctor

Other Information



  • store below 25oC (77oF)

Inactive Ingredients



Polysiloxanes, Silicon Dioxide, Isopropyl Myristate


Questions?



1-800-240-8227


Representative Labeling



bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 50g (43474-001-50)
bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 20g (43474-001-20)
bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 10g (43474-001-10)



Outer Label - OuterLabel

Outer Label - OuterLabel






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