LIDOCARE MIST- lidocaine spray
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 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 Inner Packaging

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

LIDOCAREMIST

LIDOCARE MIST
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63181-0018
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (Viscous hazy colorless to off-white liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63181-0018-1	1 in 1 BOX	04/04/2014	10/31/2015
1		20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/04/2014	10/31/2015

Labeler - Sesvalia USA LLC (061096093)

Name	Address	ID/FEI	Business Operations
Establishment
Sesderma S.L.		633606975	manufacture(63181-0018)

Revised: 10/2018

Document Id: 79287139-1ac8-ca43-e053-2a91aa0a3f09

Set id: e4e00a64-1589-4a26-aa49-8b6facaeb64e

Version: 3

Effective Time: 20181026

Sesvalia USA LLC