PAIN RELIEF CREAM- lidocream hydrochloride cream 
AEC Consumer Products

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 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

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

image of label

PAIN RELIEF CREAM 
lidocream hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86089-222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS3.86 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86089-222-0194.6 g in 1 TUBE; Type 0: Not a Combination Product09/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/23/2019
Labeler - AEC Consumer Products (080994102)
Registrant - Cospro Development Corp (785638821)
Establishment
NameAddressID/FEIBusiness Operations
Cospro Development Corp785638821manufacture(86089-222) , pack(86089-222) , label(86089-222)

Revised: 1/2021
Document Id: 0833f413-d338-48b9-af6b-7c4c70dc4a91
Set id: fe1d98da-59eb-4742-94ff-8431ea601f0c
Version: 2
Effective Time: 20210105
 
AEC Consumer Products