PAIN RELIEF CREAM- lidocream hydrochloride cream

pain relief cream by

Drug Labeling and Warnings

pain relief cream by is a Otc medication manufactured, distributed, or labeled by AEC Consumer Products, Cospro Development Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                                        Purpose
Lidocaine Hydrochloride 4%.......................................................................External Analgesic

Purpose

External Analgesic

Warning

For External use only

When using this product

When using this product use only as directed

• avoid contact with the eyes
• do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if

Stop use and ask a doctor if condition worsens symptoms persist more than 7 days

symptoms clear up and occur again with a few days

Keep out of use of children

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

Storage and Handling

Apply as needed to affectedareas 3-4 times a day.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aqua, Arnica Mountain Flower Extract, Astaxanthin, Benzyl Alcohol, BHT, Bisabolol, Boswellia Serrata Resin Extract, Cannabis Sativa Oil/Extract, Cetyl Alcohol, Citrus Aurantium Bergamia Peel Oil, Curcurria Longa Root Extract, Cyclopentasiloxane, Dimethicone, Dimethicol, Emu Oil, Ethoxydiglycol, Glucosamine, Glycerin, Glyceryl Stearate SE, Isopropyl Palmitate, Melaleuca Alternifolia Leaf Oil, Methylsulfonylmethane, PEG-100 Stearate, Phenoxyethanol, Polyquaterium-10, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate, Salicylic Acid, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopherol, Triethanolamine, Vaccinium Myrtillus Fruit/Leaf Extract

Indications

Use

For the temporary relief of pain

Do not use

Do not use in large quantities, particularly over raw or blistered surfaces for more than one week without consulting a doctor

Ask a doctor

Ask a doctor if condition worsens symptoms persist more than 7 days symptoms clear up and occur again with a few days

Directions

Adults and children over 12 years: apply as needed to affected areas 3-4 times a day. Consult a physician if pain persists. 

dosage

Apply as needed to affected areas 3-4 times a day.

image of label

INGREDIENTS AND APPEARANCE

PAIN RELIEF CREAM 
lidocream hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86089-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	3.86 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
water (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ASTAXANTHIN (UNII: 8XPW32PR7I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BISABOLOL OXIDE A (UNII: 16AE65F94Y)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
CURCUMA LONGA LEAF (UNII: H2HC4RY52C)
DIMETHICONE (UNII: 92RU3N3Y1O)
EMU OIL (UNII: 344821WD61)
ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)
GLUCOSAMINE (UNII: N08U5BOQ1K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TETRASODIUM DIETHYLENETRIAMINEPENTAMETHYLENEPHOSPHONATE (UNII: E6DVO371LC)
TOCOPHEROL (UNII: R0ZB2556P8)
VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86089-222-01	94.6 g in 1 TUBE; Type 0: Not a Combination Product	09/23/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/23/2019

Labeler - AEC Consumer Products (080994102)

Registrant - Cospro Development Corp (785638821)

Establishment
Name	Address	ID/FEI	Business Operations
Cospro Development Corp		785638821	manufacture(86089-222) , pack(86089-222) , label(86089-222)