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NDC 76420-0449-60 XOLIDO 2 g/mL Details

XOLIDO 2 g/mL

XOLIDO is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Asclemed USA, Inc. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	76420-0449
Product ID	76420-449_c8108fcb-4d62-49c7-904a-15efc3d3cdb7
Associated GPIs	90850060103724
GCN Sequence Number	071285
GCN Sequence Number Description	lidocaine HCl CREAM(ML) 2 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	35029
HICL Sequence Number	001478
HICL Sequence Number Description	LIDOCAINE HCL
Brand/Generic	Brand
Proprietary Name	XOLIDO
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/mL
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Asclemed USA, Inc
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 76420-0449-60 (76420044960)

Pricing Information	N/A
NDC Package Code	76420-449-60
Billing NDC	76420044960
Package	118 mL in 1 BOTTLE (76420-449-60)
Marketing Start Date	2013-04-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f2b463d7-3fcf-4b2c-8ba2-8e51e3290de2 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Lidocaine HCl 2%

Purpose

External Anaesthetic

Uses

For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburn, and minor burns.

Warnings

: - For external Use only
: - Avoid contact with eyes.

: - If symptoms persist for more than seven days, or clear up and occur again within a few day, discontinue use and consult physician.

: - If redness, irritation, swelling, pain or other symptoms increase, discontinue use and consult physician.

: - Keep out of reach of children. If swallowed, consult physician.

Directions

For adults and children two-years and older, apply externally to the affected area. Do not use more than three to four times per day.

Inactive Ingredients

Aqua (Deionized Water), C13-14 Isoparaffin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Methylisothiazolinone, Polyacrylamide, Stearic Acid.

Principal Display Panel

Xolido 2%

Pain Relief Cream

4 oz (118 mL)

Distributed by:

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

INGREDIENTS AND APPEARANCE

XOLIDO

lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-449
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76420-449-60	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/05/2013

Labeler - Asclemed USA, Inc (059888437)

Revised: 6/2017

Document Id: c8108fcb-4d62-49c7-904a-15efc3d3cdb7

Set id: f2b463d7-3fcf-4b2c-8ba2-8e51e3290de2

Version: 2

Effective Time: 20170619