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Lidocaine by PD-Rx Pharmaceuticals, Inc.

Medically reviewed on May 15, 2017

Dosage form: cream
Ingredients: LIDOCAINE 4g in 100g
Labeler: PD-Rx Pharmaceuticals, Inc.
NDC Code: 68752-024

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.

Lidocaine 4%

Active Ingredient


Lidocaine 4% w/w

Purpose

Topical anesthetic

Use

temporarily relieves pain and itching due to

  • minor cuts
  • minor scrapes
  • minor burns
  • sunburn
  • minor skin irritations
  • minor bites

WARNINGS:

For external use only

When using this product

Do not use

  • in or near the eyes
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use

Stop use and ask doctor if:

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age: Consult a doctor

Other Information
  • May be applied under occlusive dressing
  • Store at 25  deg. C (77F); excursions permitted to 15-30 deg. C (59-86F)
  • [see USP Controlled Room Temperature].

Inactive ingredients

water, cetyl alcohol, stearic acid, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil,

lecithin, hexylene glycol, sodium polyacrylate, caprylyl glycol, ethoxydiglycol, potassium sorbate, phenoxyethanol

Lidocaine 4%

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68752-024
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETYL ALCOHOL 
STEARIC ACID 
ALOE VERA LEAF 
JOJOBA OIL 
HEXYLENE GLYCOL 
CAPRYLYL GLYCOL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
POTASSIUM SORBATE 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:68752-024-451 TUBE in 1 CARTON
145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2011
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIOperations
PD-Rx Pharmaceuticals, Inc.156893695manufacture(68752-024)

 
PD-Rx Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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