SESDERMA SESPREVEX CALMING AND PROTECTING FOAM- zinc oxide aerosol, foam 
Sesvalia USA LLC

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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Sesderma SESPREVEX Calming and protecting foam

Drug Facts

Active ingredient

Zinc Oxide 14%

Purpose

Skin Protectant

Uses

Dries the oozing and weeping of poison:

  •  ivy 
  • oak 
  • sumac

Warnings

For external use only

When using this product

do not get into eyes.

Stop use and ask a doctor

■ conditions worsen

■ symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

 If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply as needed.

Inactive Ingredients

Benzyl Alcohol, Butane, Glycerin, Isobutane, Peg-6 Caprylic/capric Glycerides, Polysorbate 80, Potassium Sorbate, Propane, Tocopheryl Acetate, Water.

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

SESPREVEX Skin protectant foam 1.7 fl oz (50 mL) (63181-0014-1)

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

SESDERMA SESPREVEX CALMING AND PROTECTING FOAM 
zinc oxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63181-0014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION140 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Viscous hazy colorless to off-white liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63181-0014-11 in 1 BOX04/07/201410/31/2015
150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/07/201410/31/2015
Labeler - Sesvalia USA LLC (061096093)
Establishment
NameAddressID/FEIBusiness Operations
Sesderma S.L.633606975manufacture(63181-0014)

Revised: 10/2018
Document Id: 79280d49-f58b-f16a-e053-2991aa0ab6a0
Set id: 11466a32-eb49-4ab8-8427-4feb2a1c7c74
Version: 2
Effective Time: 20181026
 
Sesvalia USA LLC