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NDC 76420-0451-01 XOLIDO 4 g/mL Details

XOLIDO 4 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	76420-0451
Product ID	76420-451_ead450b0-177a-2b5f-e053-2995a90a6572
Associated GPIs	90850060103735
GCN Sequence Number	072055
GCN Sequence Number Description	lidocaine HCl CREAM(ML) 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	36146
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	4
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 76420-0451-01 (76420045101)

Pricing Information	N/A
NDC Package Code	76420-451-01
Billing NDC	76420045101
Package	118 mL in 1 BOTTLE (76420-451-01)
Marketing Start Date	2013-04-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e29c46ce-6758-41ff-af1a-e99fb67a8c33 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Lidocaine HCl 4%

Purpose

External Anesthetic

Uses

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

Warning

For external use only.

Avoid contact with eyes

Stop using this product and ask doctor If

symptoms last for more than seven days, or clear up and occur again within a few days
if redness, irritation, swelling, pain or other symptoms increase

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Additional Information

Store at room temperature.

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

NDC 76420-451-01

Xolido XP 4%

Pain Relief Cream

4 OZ (118 mL)

Distributed by:

Enovachem Manufacturing

Torrance, CA 90501

(310) 218-4146

INGREDIENTS AND APPEARANCE

XOLIDO

lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-451
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 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:76420-451-01	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: 10/2022

Document Id: ead450b0-177a-2b5f-e053-2995a90a6572

Set id: e29c46ce-6758-41ff-af1a-e99fb67a8c33

Version: 4

Effective Time: 20221012