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XOLIDO by Asclemed USA, Inc

Medically reviewed on June 19, 2017

Dosage form: cream
Ingredients: LIDOCAINE HYDROCHLORIDE 2g in 1mL
Labeler: Asclemed USA, Inc
NDC Code: 76420-449

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.

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

XOLIDO 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-449
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
C13-14 ISOPARAFFIN 
GLYCERYL MONOSTEARATE 
HELIANTHUS ANNUUS FLOWERING TOP 
ISOPROPYL MYRISTATE 
LAURETH-7 
METHYLISOTHIAZOLINONE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:76420-449-60118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/05/2013
Labeler - Asclemed USA, Inc (059888437)

 
Asclemed USA, 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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