NDC Code(s) : 63181-0014-1
Packager : Sesvalia USA LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sesderma SESPREVEX Calming and protecting foamZINC OXIDE AEROSOL, FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63181-0014
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION140 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTANE(UNII: 6LV4FOR43R)
GLYCERIN(UNII: PDC6A3C0OX)
ISOBUTANE(UNII: BXR49TP611)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES(UNII: GO50W2HWO8)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PROPANE(UNII: T75W9911L6)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (Viscous hazy colorless to off-white liquid) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63181-0014-11 in 1 BOX
150 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 04/07/2014

PRINCIPAL DISPLAY PANEL

SESPREVEX

Skin protectant foam

14% Zinc Oxide

Calming and

protecting foam

1.7 fl oz (50 mL)

sesderma

Manufactured by:

SESDERMA S.L. Pol. Industrial Rafelbuñol. C/ Massamagrell, 5. 46138 Rafelbuñol.Valencia (Spain)

Customer service: 902 100 223.

Distributed by:

SESVALIA USA LLC.

67 Miracle Mile, Coral Gables, FL 33134 USA. USA

Customer service: (1) 800 796 0996.

www.sesderma.com

Made in SPAIN

SESPREVEXLabel