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Sesderma SESPREVEX Calming and protecting foam

Dosage form: aerosol, foam
Ingredients: ZINC OXIDE 140mg in 1mL
Labeler: Sesvalia USA LLC
NDC Code: 63181-0014

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.

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

SESDERMA SESPREVEX CALMING AND PROTECTING FOAM 
zinc oxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63181-0014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION140 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTANE 
GLYCERIN 
ISOBUTANE 
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES 
POLYSORBATE 80 
POTASSIUM SORBATE 
PROPANE 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
Product Characteristics
ColorWHITE (Viscous hazy colorless to off-white liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63181-0014-11 BOTTLE, SPRAY in 1 BOX
150 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/07/2014
Labeler - Sesvalia USA LLC (061096093)
Establishment
NameAddressID/FEIOperations
Sesderma S.L.633606975MANUFACTURE(63181-0014)

Revised: 04/2014
 
Sesvalia USA LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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