Planticin Advanced Topical Pain Relief (Lidocaine) Cream [Pedicis Research, Llc] -

PLANTICIN ADVANCED TOPICAL PAIN RELIEF (LIDOCAINE) CREAM [PEDICIS RESEARCH, LLC]
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NDC	51151-738-01
Set ID	61744544-8bcd-4760-930a-42615e32b12b
Category	HUMAN OTC DRUG LABEL
Packager	Pedicis Research, LLC
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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Drug Facts:
Active Ingredients:

Lidocaine 4% w/w

Purpose

Topical Analgesic
Uses:

For the temporary relief of pain
Warnings:

• For External Use only • Avoid contact with the eyes • Flammable. Keep away from fire and flame • Cap tube tightly and store at room temperature away from heat

When using this product:

• do not use in large quantities particularly over raw surfaces or blistered areas • do not exceed recommended doses unless recommended by a doctor

Stop use and ask a doctor if:

• allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and do not return within a few days • you notice any unusual effects

Keep out of the reach of children:

If swallowed get medical help or call a Poison Control Center right away
Directions:

• Adults or children 2 years of age and older. Apply externally to affected area not more than 3-4 times daily. • Children under 2 years of age consult a doctor
Inactive Ingredients:

arnica, dimethyl sulfoxide, echinacea, hydroxypropyl cellulose, isopropyl alcohol, propylene glycol
Questions:

Call toll free 1-800-748-6539
Package Labeling:

INGREDIENTS AND APPEARANCE

PLANTICIN ADVANCED TOPICAL PAIN RELIEF
lidocaine cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51151-738-01	1 in 1 BOX	04/21/2016
1		60 g in 1 TUBE; 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	04/21/2016

Labeler - Pedicis Research, LLC (078496974)

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Medic