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LIDOCARE MIST

Sesvalia USA LLC

Sesderma LIDOCARE MIST


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Lidocaine 2%

Purpose

Topical anlgesic

LIDOCARE MIST 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

LIDOCARE MIST

Lidocaine SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63181-0018
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LIDOCAINE LIDOCAINE 20 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
PHENOXYETHANOL
POLYSORBATE 20
water

Product Characteristics

Color
WHITE (Viscous hazy colorless to off-white liquid)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BOTTLE, SPRAY
2 NDC:63181-0018-1 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2014-04-04


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Be sure to consult your doctor before taking any medication!
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