Pain Relief Cream: Package Insert and Label Information

PAIN RELIEF CREAM- lidocaine 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.

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

image of label
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PAIN RELIEF CREAM
lidocream hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:86089-222
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 3.86 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
water
ARNICA MONTANA FLOWER
ASTAXANTHIN
BENZYL ALCOHOL
BISABOLOL OXIDE A
CANNABIS SATIVA SEED OIL
CETYL ALCOHOL
CITRUS AURANTIIFOLIA FRUIT OIL
CURCUMA LONGA LEAF
DIMETHICONE
EMU OIL
ETHOXYDIGLYCOL BEHENATE
GLUCOSAMINE
GLYCERYL STEARATE SE
ISOPROPYL PALMITATE
MELALEUCA ALTERNIFOLIA LEAF
PEG-100 STEARATE
PHENOXYETHANOL
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)
POTASSIUM SORBATE
PROPYLENE GLYCOL
SODIUM HYDROXIDE
STEARIC ACID
STEARYL ALCOHOL
TETRASODIUM DIETHYLENETRIAMINEPENTAMETHYLENEPHOSPHONATE
TOCOPHEROL
VACCINIUM MYRTILLUS LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86089-222-01 94.6 g in 1 TUBE None
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 Operations
Cospro Development Corp 785638821 manufacture (86089-222), pack (86089-222), label (86089-222)

Revised: 01/2021 AEC Consumer Products

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