Procicept L by Nocicept Technologies, Inc. Drug Facts

Procicept L by

Drug Labeling and Warnings

Procicept L by is a Otc medication manufactured, distributed, or labeled by Nocicept Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROCICEPT L LIDOCAINE 4%- lidocaine and menthol liquid 
Nocicept Technologies, Inc.

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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Drug Facts

Active Ingredients                              Purpose

Lidocaine 4%                                         Topical Anesthetic

Menthol 1%                                           Topical Analgesic

Uses

Temporarily relieves minor pain.

Warnings

For external use only

Do not use
On large areas of the body or on cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor

When using this product

Use only as directed

Read and follow all direction and warnings on this carton

Do not allow contact with eyes

Do not bandage or apply local heat (such as heating pads) to the area of use

Stop using and ask a doctor if

Condition worsens

Symptoms persist for more than 7 days or clear up and occur again within a few days

When pregnant or breastfeeding, ask a health professional before use

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children over 12 years of age

Apply generously (about the thickness of a nickel) to the affected area as needed, not to exceed 3 applications

Children 12 years and younger

Ask a doctor

Inactive ingredients

benzyl alcohol, soy lecithin, isopropyl palmitate, poloxamer, sorbic acid

PROCICEPT L  LIDOCAINE 4%
lidocaine and menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70458-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLOXAMER 124 (UNII: 1S66E28KXA)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70458-101-02	1 in 1 CARTON	02/01/2017	12/31/2019
1		5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 70458-101-07	1 in 1 CARTON	02/01/2017	12/31/2019
2		7.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2017	12/31/2019

Labeler - Nocicept Technologies, Inc. (080111681)

Revised: 1/2018

Document Id: 617acb8f-c519-445a-bc34-c6bf50f910f4

34390-5

Set id: 896faf91-527d-4de2-a2bb-28169bf957dc

Version: 6

Effective Time: 20180120

 

Nocicept Technologies, Inc.