Label # 1 NDA 21-604 / S004
CFR Section Section of Font Specifications Elixsure Label Text Subheading(s) Heading 201.66 (c)(1) “Drug Facts N/A N/A Helvetica Bold (Continued)” Italic- 8 pt 201.66 (c)(2) “Active Helvetica- 6 pt N/A Helvetica Bold Ingredient” Italic- 8 pt 201.66 (c)(3) “Purpose” N/A N/A Helvetica Bold Italic- 8 pt 201.66 (c)(4) “Uses” Helvetica- 6 pt N/A Helvetica Bold Italic- 8 pt 201.66 (c)(5) “Warnings” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(6) “Directions” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(7) “Other Helvetica- 6 pt N/A Helvetica Bold Information” Italic- 8 pt 201.66 (c)(8) “Inactive Helvetica- 6 pt Helvetica Bold- N/A Ingredients” 6 pt 201.66 (c)(9) “Questions or Helvetica- 6 pt N/A Helvetica Bold comments?” Italic- 8 pt
Further Font Specifications:
201.66(d)(3) Leading: 1 pt
Number of Characters per Inch: < 39
201.66(d)(4) Point Size of Bullets: 6 pt (same as character size)
Reference ID: 3480500
Label # 3 NDA 21-604 / S004
CFR Section Section of Font Specifications Elixsure Label Text Subheading(s) Heading 201.66 (c)(1) “Drug Facts N/A N/A N/A (Continued)” 201.66 (c)(2) “Active Helvetica- 6 pt N/A Helvetica Bold Ingredient” Italic- 8 pt 201.66 (c)(3) “Purpose” N/A N/A N/A 201.66 (c)(4) “Uses” Helvetica- 6 pt N/A Helvetica Bold Italic- 8 pt 201.66 (c)(5) “Warnings” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(6) “Directions” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(7) “Other N/A N/A N/A Information” 201.66 (c)(8) “Inactive N/A N/A N/A Ingredients” 201.66 (c)(9) “Questions or Helvetica- 6 pt N/A Helvetica Bold comments?” Italic- 8 pt
Further Font Specifications:
201.66(d)(3) Leading: 1 pt
Number of Characters per Inch: < 39
201.66(d)(4) Point Size of Bullets: 6 pt (same as character size)
Reference ID: 3480500
Label # 4 NDA 21-604 / S004
CFR Section Section of Font Specifications Elixsure Label Text Subheading(s) Heading 201.66 (c)(1) “Drug Facts N/A N/A Helvetica Bold (Continued)” Italic- 8 pt 201.66 (c)(2) “Active Helvetica- 6 pt N/A Helvetica Bold Ingredient” Italic- 8 pt 201.66 (c)(3) “Purpose” N/A N/A Helvetica Bold Italic- 8 pt 201.66 (c)(4) “Uses” Helvetica- 6 pt N/A Helvetica Bold Italic- 8 pt 201.66 (c)(5) “Warnings” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(6) “Directions” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(7) “Other Helvetica- 6 pt N/A Helvetica Bold Information” Italic- 8 pt 201.66 (c)(8) “Inactive Helvetica- 6 pt Helvetica Bold- N/A Ingredients” 6 pt 201.66 (c)(9) “Questions or Helvetica- 6 pt N/A Helvetica Bold comments?” Italic- 8 pt
Further Font Specifications:
201.66(d)(3) Leading: 1 pt
Number of Characters per Inch: < 39
201.66(d)(4) Point Size of Bullets: 6 pt (same as character size)
Reference ID: 3480500
Label # 5 NDA 21-604 / S004
CFR Section Section of Font Specifications Elixsure Label Text Subheading(s) Heading 201.66 (c)(1) “Drug Facts N/A N/A N/A (Continued)” 201.66 (c)(2) “Active Helvetica- 6 pt N/A Helvetica Bold Ingredient” Italic- 8 pt 201.66 (c)(3) “Purposes” Helvetica- 6 pt N/A Helvetica Bold Italic- 8 pt 201.66 (c)(4) “Uses” N/A N/A N/A 201.66 (c)(5) “Warnings” N/A N/A N/A 201.66 (c)(6) “Directions” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(7) “Other N/A N/A N/A Information” 201.66 (c)(8) “Inactive N/A N/A N/A Ingredients” 201.66 (c)(9) “Questions or N/A N/A N/A comments?”
Further Font Specifications:
201.66(d)(3) Leading: 1 pt
Number of Characters per Inch: < 39
201.66(d)(4) Point Size of Bullets: 6 pt (same as character size)
Reference ID: 3480500
Label # 2 NDA 21-604 / S004
CFR Section Section of Font Specifications Elixsure Label Text Subheading(s) Heading 201.66 (c)(1) “Drug Facts N/A N/A Helvetica Bold (Continued)” Italic- 8 pt 201.66 (c)(2) “Active Helvetica- 6 pt N/A Helvetica Bold Ingredient” Italic- 8 pt 201.66 (c)(3) “Purpose” N/A N/A Helvetica Bold Italic- 8 pt 201.66 (c)(4) “Uses” Helvetica- 6 pt N/A Helvetica Bold Italic- 8 pt 201.66 (c)(5) “Warnings” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(6) “Directions” Helvetica- 6 pt Helvetica Bold- Helvetica Bold 6 pt Italic- 8 pt 201.66 (c)(7) “Other Helvetica- 6 pt N/A Helvetica Bold Information” Italic- 8 pt 201.66 (c)(8) “Inactive Helvetica- 6 pt Helvetica Bold- N/A Ingredients” 6 pt 201.66 (c)(9) “Questions or Helvetica- 6 pt N/A Helvetica Bold comments?” Italic- 8 pt
Further Font Specifications:
201.66(d)(3) Leading: 1 pt
Number of Characters per Inch: < 39
201.66(d)(4) Point Size of Bullets: 6 pt (same as character size)
Reference ID: 3480500 ------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. ------/s/ ------THERESA M MICHELE 03/31/2014
Reference ID: 3480500