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LIDOCARE MIST

Medically reviewed on March 23, 2018

Dosage form: spray
Ingredients: LIDOCAINE 20mg in 1mL
Labeler: Sesvalia USA LLC
NDC Code: 63181-0018

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 LIDOCARE MIST

Drug Facts

Active ingredient

Lidocaine 2%

Purpose

Topical anlgesic

Uses

■ for the temporary relief of pain associated with minor skin irritations.

Warnings

For external use only

Do not use

■ in large quantities, particularly over raw surfaces or blistered areas.

■ on broken skin.

■ on irritated skin.

When using this product

■ avoid contact with the eyes.

■ in case of contact, rinse off with water.

Stop use and ask a doctor

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

■ irritation occurs.

Keep out of reach of children.

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

Directions

■ adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.

■ children under 2 years of age: Consult a doctor.

■ apply product using fingertips or cotton ball.

Inactive Ingredients

Alcohol, Lecithin, Phenoxyethanol, Polysorbate 20, 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

Sesderma LIDOCARE MIST 0.68 fl oz / 20ml  (63181-0018-1)

LIDOCARE

MIST

Lidocaine

Topical analgesic

0.68 fl oz (20 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

LIDOCARE MIST 
lidocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63181-0018
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
PHENOXYETHANOL 
POLYSORBATE 20 
WATER 
Product Characteristics
Colorwhite (Viscous hazy colorless to off-white liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63181-0018-11 BOTTLE, SPRAY in 1 BOX
120 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/04/2014
Labeler - Sesvalia USA LLC (061096093)
Establishment
NameAddressID/FEIOperations
Sesderma S.L.633606975manufacture(63181-0018)

 
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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