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Xyralid

Medically reviewed on July 6, 2017

Dosage form: cream
Ingredients: LIDOCAINE 5g in 100g
Labeler: Innovus Pharmaceuticals, Inc.
NDC Code: 57483-108

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.

Xyralid - lidocaine 5% cream

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external use only.

When using this product
  • avoid contact with the eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any other mechanical device or applicator

Stop and ask a doctor if
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 day
  • allergic reaction occurs to ingredients in this product
  • symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symtpoms clear up and return within a few days

Keep out of reach of children.

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

Directions
  • When practical, clean area with mild soap and warm water and rinse thoroughly, Gently dry by patting or blotting wiht toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: Apply externally to the affected are up to six times a day
  • Children under 12 years of age: Consult a doctor

Other information

Store at 20-25oC (66-77oF) [see USP Controlled Room Temperature].

Inactive ingredients

cetyl alcohol, glyceryl stearate, glyceryl stearate SE, methylparaben, PEG-100 stearate, pertrolatum, propylene glycol, propylparaben, water, white beeswax

XYRALID 
lidocaine 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-108
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
GLYCERYL STEARATE SE 
METHYLPARABEN 
PEG-100 STEARATE 
PETROLATUM 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
WHITE WAX 
Packaging
#Item CodePackage Description
1NDC:57483-108-0530 PACKET in 1 CARTON
1.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/06/2017
Labeler - Innovus Pharmaceuticals, Inc. (962507187)
Registrant - Innovus Pharmaceuticals, Inc. (962507187)

 
Innovus Pharmaceuticals, Inc.

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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