XYRALID- lidocaine 5% cream

Xyralid by

Drug Labeling and Warnings

Xyralid by is a Otc medication manufactured, distributed, or labeled by Innovus Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XYRALID 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-108
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-108-05	30 in 1 CARTON	07/14/2017
1		.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/06/2017

Labeler - Innovus Pharmaceuticals, Inc. (962507187)

Registrant - Innovus Pharmaceuticals, Inc. (962507187)